The Paracelsus Private Medical University (PMU) in Salzburg is to build a new research center for spinal cord injuries. The €70m construction tab will be picked up by Dietrich Mateschitz, the owner of Red Bull. Other partners in the project include the province of Salzburg, Salzburg’s University Hospital and the Foundation for Spinal Cord Research “Wings for Life”, which was also founded by Mateschitz. The new facility in Salzburg will focus on several research areas, including stem cells, the regeneration of nerve cells and molecular approaches to restoring injured nerve connections. Other priorities include the prevention of secondary damage after spinal cord injuries have occurred, and compensation therapies that rely on stimulation of nerves and patient rehabilitation. “This is the third largest amount that a European university has ever received from an individual,” said PMU Rector Herbert Resch. Construction will begin in the first half of 2012. It will host numerous research and teaching facilities on 8,000m2. “The close integration of basic science and clinical research on new cross-sectional and tissue regeneration will be one of the great features of the new facilities,” stressed Resch. In all, these will employ three research professors and around 40 staff.
London – The European Medicines Agency (EMA) will publish information about all drugs under review, beginning on March 1. On a monthly basis the company will issue a list disclosing the international non-proprietary name and...
London – The European Medicines Agency (EMA) will publish information about all drugs under review, beginning on March 1. On a monthly basis the company will issue a list disclosing the international non-proprietary name and therapeutic areas of each product under review as well as information on the type of salt, ester or derivative of the active ingredient. Until now, EMA has published information just about orphan drugs under review. Information on other products will not be released until the Committee for Medicinal Products for Human Use (CHMP) has issued an opinion. The plan is part of the agency ’s new policy on transparency and access to documents. The agency will also assume more responsibility in the field of pharmacovigilance. Up to now, the EMA focused its post-marketing drug safety monitoring on the 568 centrally authorised medicines for human use. But as of mid-July, the EU drug watchdog will stepwise include pharmacovigilance data from nationally authorised medicines. The newly formed Pharmacovigilance Risk Assessment Committee (PRAC) will be responsible for the implementation of the new European drug safety rules.
Brussels – The European Commission has adopted a strategy to set the European economy on a biological base. "Europe needs to make the transition to a post-petroleum economy", said Commissioner for Research, Innovation and Science...
Brussels – The European Commission has adopted a strategy to set the European economy on a biological base. "Europe needs to make the transition to a post-petroleum economy", said Commissioner for Research, Innovation and Science Máire Geoghegan-Quinn. "It is no longer just an option, it is a necessity."The goal for the strategy and action plan, “Innovating for Sustainable Growth: a Bioeconomy for Europe” has a host of aims: a more innovative and low-emissions economy, reconciling demands for sustainable agriculture and fisheries, food security, and the sustainable use of renewable biological resources for industrial purposes, while ensuring biodiversity and environmental protection. Three key aspects are mentioned: developing new technologies and processes for the bioeconomy; developing markets and competitiveness in bioeconomy sectors; and pushing policymakers and stakeholders to work more closely together. The EU bioeconomy already has a turnover of nearly €2 trillion and employs more than 22 million people, 9% of total employment in the EU, the commission said. The hope is that each euro invested in EU-funded bioeconomy research and innovation is will trigger €10 of value added in bioeconomy sectors by 2025.
Brusssels/Manila - The acreage of GM crops is on the rise worldwide - even in Europe. Roughly 160 million hectares were planted with biotech crops in 2011, up 8 per cent from 2010, the International Service for the Acquisition of...
Brusssels/Manila - The acreage of GM crops is on the rise worldwide - even in Europe. Roughly 160 million hectares were planted with biotech crops in 2011, up 8 per cent from 2010, the International Service for the Acquisition of Agri-Biotech Applications (ISAAA) said in its new annual report. The biotech crops were planted by 16.7 million farmers in 29 countries, up from 15.4 million farmers in the same number of countries in 2010. In Europe the acreage grow by 20%. That is mostly because of the enthusiasm Spain is demonstrating. According to government figures Spanish farmers planted 97,300 hectares of the gm-maize MON810 in 2011. That is a dramatic uptake from the 76,600 hectares in 2010. Spain's smaller neighbour Portugal raised the stakes, too. From 4,900 hectares the acreage of MON810 grew to 7,700 hectares. In the rest of Europe the numbers are much more modest or even moody: In the Czech Republic there was a slight increase from 4,700 to 5,100 hectares, Poland was stable at 3,000 hectares, Slovakia and Romania are practically free of MON810. The only other crop approved for cultivation in Europe, the potato Amflora made by BASF, will be gone from the continent in 2012. The little patches in Sweden and Germany, where the plant was raised in 2011, will be given up. Not only Amflora leaves Europe, its inventors follow suit
London/Brussels - The exodus of plant biotechnology out of Europe seems to have accelerated. Just three weeks ago, BASF Plant Science announced it would leave Europe as an R&D location for developing its GM plants. But now,...
London/Brussels - The exodus of plant biotechnology out of Europe seems to have accelerated. Just three weeks ago, BASF Plant Science announced it would leave Europe as an R&D location for developing its GM plants. But now, it looks like US-based Monsanto is following the example of its German R&D partner and turning away from Europe for good. First, the company announced that it does not plan to sell its genetically modified maize MON810 in France despite the highest court recently overturning a three-year ban on its sale. Now United Press International reported that Monsanto is closing its wheat growing operation, based in Cambridge, which employed 125 people, and selling off crop-breeding centers in France, Germany and the Czech Republic. That the news was withdrawn shortly after publication did nothing to damp down the rumours. Meanwhile the Danish government is trying to find a way around the divisive mood that bogs down the approval of GM plants in Europe. "There is a blocking minority on the GMO proposals, and we are trying to do our utmost to find a solution and get agreement among member states," said a spokesman for the Danish EU presidency. Under the draft seen by news agency Reuters, companies seeking EU approval for a GM crop would agree not to market the product in those countries that wish to restrict cultivation, in return for them not blocking EU authorisation to grow the crops elsewhere in Europe.
Brussels – Predicting the future is often not more than a guessing game. But two signs recently appeared on the horizon which indicate that the biotechnology industry will play a dominant role in the dynamics of EU economics in...
Brussels – Predicting the future is often not more than a guessing game. But two signs recently appeared on the horizon which indicate that the biotechnology industry will play a dominant role in the dynamics of EU economics in 2012 and beyond. The first one is the notion that 85% of net new jobs in the EU between 2002 and 2010 were created by small and medium sized enterprises (SMEs). This means that SMEs with a 67% share in total employment punch considerably above their weight when it comes to creating new jobs. Most biotechs are SMEs. The numbers are the result of a study which looked at the essential contribution of SMEs on job creation between 2002 and 2010 and which was published by the European Commission. The second sign for an active role of biotechnology in the European economy in 2012 was spotted by Bloomberg. The service provider indicates that Europe’s largest drugmakers will invest heavily in acquisitions of biotechnology companies this year. The value of acquisitions announced by Europe’s ten largest pharmaceutical companies plunged to €1.65bn in 2011 from €33.5 billion the year before. But facing a steep patent cliff – there's talk of a whopping EUR16.5bn loss of sales due to patent expirations – the companies will go on a buying spree, Bloomberg predicts. "You can never have enough pipeline", analyst Les Funtleyder told Bloomberg. And biotech companies are cheap right now, some of them trade at only twice the value of their cash reserves alone.
Innsbruck/Brussels - Twelve institutions in seven countries are working together to learn more about how one of the deadliest cancers interacts with its environment. The consortium OPTATIO (OPtimizing TArgets and Therapeutics In...
Innsbruck/Brussels - Twelve institutions in seven countries are working together to learn more about how one of the deadliest cancers interacts with its environment. The consortium OPTATIO (OPtimizing TArgets and Therapeutics In high risk and refractOry Multiple Myeloma) unites companies and research bodies from Austria, Germany, the Czech Republic, Italy, Hungary, the United Kingdom and Spain. Under the umbrella of the Seventh Framework Programme of the European Union the team, led by Wolfgang Willenbacher of Innsbruck university, will look into the unique ecosystem of different cells in the bone marrow, where myeloma cells are born. The cancer always starts with one of the mature b-cells of the immune system, which suddenly starts to degenerate. The budding myeloma cell then starts to build up an increasing exchange of signalling hormones with surrounding osteoblasts, osteoclasts, blood vessel cells and other cells of the immune system. This "concert" of interactions seems to hide the myeloma cells from the attacks with cytoxins and therefore renders existing drugs more or less ineffective. To reveal the workings of this resistance mechanism is one goal of OPTATIO. Another is to find out why 99% of the patients who bear a precursor of the myeloma cells, stay perfectly healthy while the unlucky 1% develop the disease which in most cases is still incurable. The project goes on until 2014 and is funded with EUR3m.
After years of strong double-digit value growth, the biologics market has recently stuttered, seeing year-on-year growth fall below 10%. As product space grows increasingly crowded, future success will depend on opening up the...
After years of strong double-digit value growth, the biologics market has recently stuttered, seeing year-on-year growth fall below 10%. As product space grows increasingly crowded, future success will depend on opening up the market through expansion into new therapy areas, offering new MOAs and successfully exploiting the opportunity in pharmerging and biosimilars markets. This is a valuable market to play in, and for those who get their strategy right, returns could be high indeed. IMS currently measures the global biologics market* worth at more than US$150bn – that’s 18% by value of total pharmaceutical sales. If biologics were a country, it would be second in spending worldwide behind the US. Contribution of biologics to total pharma sales has also risen noticeably: value growth in the area has been rapid (14.0% CAGR since 2001). Despite the initial success and uptake of biologics, however, growth rates are clearly down on the early part of the decade, and are bolstered only by a strong US market. With crowded product offerings, a relative lack of innovation, copycat products and the introduction of biosimilars – are biologics entering a new era with lower growth rates and a tougher market environment?
Increasingly crowded shelves mean a tougher market
Biologics are still driven by specialist treatments. Only 25% of the overall market is accounted for by primary care, and within this, almost all of the value comes from vaccines and antidiabetics. Leading therapy areas in terms of sales value for biologics over the last five years have consistently been oncologics, autoimmune agents, antidiabetics, vaccines and erythropoietins. With a rush to launch products into these proven successful therapy areas, many companies are now going through what Small Molecule (SM) market firms experienced a few years ago – diminishing RoI. Consider the monoclonal antibodies currently on the market for oncology (ATC class L1X3). By the end of the 1990s, just two such products had been launched – Mabthera and Herceptin. By 2005, that number had climbed to eight, and today it stands at 14. But 96% of revenue value is still held by just four of these 14 products. Avastin, Mabthera, Herceptin and Erbitux – which were all launched before 2005 – continue to dominate the market. This is illustrated in Fig. 3, where we plot the normalised cumulative post-launch sales from Q1–Q12 (up to three years). Avastin, Mabthera, Herceptin and Erbitux show a strong increase in sales, but sales from the other 10 Mabs on a per molecule basis have failed to replicate this impact. Biologics for autoimmune treatment reveal a similar picture. At the end of the 1990s, there were only two anti-TNF biologics (Enbrel and Remicade). By 2005 there were three, and today there are five products on the market. Just as with the oncological Mabs, there is a stark difference in revenue achievement between the products, with recent launches performing less well in terms of sales. This lack of impact comes despite a widespread geographical roll-out. Among the blockbusters (global sales of US$1bn+) in each group, recent launches achieved faster geographical penetration than their predecessors – for example, according to IMS data, Avastin was present in 45 countries at three years vs. Herceptin in 30 countries. Likewise Humira was present in 31 countries three years after launch vs. Enbrel in 16 countries. But despite the widespread nature of the post-2005 launches, they are not achieving the same returns the earlier launches generated. Launched in 2009, Simponi is present in 24 countries at Q9 post-launch, placing it in the same league as Humira (25 countries at Q9), yet it sees only a fraction of the sales. This of course raises the question - why continue to launch biologic products into crowded therapy areas where sales 2-3 years post-launch are failing to impact the market as much as for earlier entrants? In the anti-TNF market, the five molecules illustrated all compete for a similar patient population. Being first to market brought significant advantages, and although Humira made inroads on Enbrel and Remicade due to a widespread roll-out after its launch in 2003, as well as its advantageous administration and immunogenicity, the market has remained essentially split three ways ever since. More recent launches have made much less of an impact, because the market is already sewn up. In contrast, the oncological Mabs do not always compete directly with each other in a target patient group. Large unserved patient populations existed when the first oncological Mabs were launched. With well-established products now on the market, many later entrants have turned to targeting specific patient populations, where successful treatment outcomes are more predictable and payers can be convinced to consider new entrants. Before launching products such as Erbitux and Vectibix, their manufacturers first identified biomarkers for EGFR or KRAS in order to target patients who will best respond to their treatment. Arzerra has also been granted orphan drug status by the EMA and FDA for treating a niche patient group.[2,3] Although strategies like this are not in general lifting sales performances of recent launches to that of earlier oncologic Mabs, they are still succeeding in more focused market positions.
Where is the innovation?
Core biologics therapy areas are still dominating research, with over 600 biologics in the pipeline for oncology alone. The IMS R&D Focus reveals that around 50% of the biologics pipeline is taken up with oncology and vaccines. However, there are also exciting projects targeting potential expansion beyond these core areas. Biologics are also in the pipeline for traditionally primary care areas, among them cardio, dermatology and even CNS. For example, bapineuzumab is a monoclonal antibody indicated for the treatment of mild-to-moderate Alzheimer’s disease that is being developed by J&J and Pfizer (currently Phase III). Future growth in the biologics market could rely heavily on expansion into new therapy areas like this. However, whilst in specialist areas such as Alzheimers with significant unmet need there may well be an opening for a biologic,
efforts to expand further into primary care areas such as the osteoporosis market have met with limited success. The osteoporosis market is still dominated by SM treatments – biologics such as Forteo and Prolia have between them only managed to take 13% of the market value. They also have a startling low market volume (standard units) as SM generics grow in terms of volume share. In primary care areas where payer pressure is strong, plentiful SM generics make biologics likely to be seen at best as second-line treatments, and achieving RoI will be challenging. Assessing the biologic pipeline by MOA novelty across several therapy areas shows that companies are sticking with proven classes, such as recombinant proteins, monoclonal antibodies and peptides. Newer mechanisms like mRNA translation are fewer and further between. For example, of the biologics in the pipeline for oncology, 60% are monoclonal antibodies and only 10% are antisense. So why the lack of innovation in a relatively nascent, high-growth area? Development and manufacturing costs for biologics are high, and require a major upfront investment. With regulatory (and acceptance) risks likely to be higher for completely novel MOAs, companies seem to be playing it safe.
Pharmerging markets: friend or foe?
With growth decelerating in the mature markets, pharmerging markets are becoming increasingly important to the global biologics market. The US is still at the top of the biologic market list, but China and Russia are #9 and #10 respectively, with Turkey at #14. Growth there is also impressive. Sales in the year to June 2011 were 10% higher than in the year to June 2010 in the US; in China they were 21% higher. The pharmerging markets therefore offer opportunity just as the biologics market is starting to feel the impact of declining growth in Europe and increasingly crowded product space in the mature US market. Much of pharmerging growth, however, is driven by so-called “other biosimilar-type products”, which are characteristic across the region. Dr Reddy’s has launched Reditux in India, which is based on Roche’s blockbuster rituximab (Rituxan). Hayao Biologic has launched XueDaSheng in China, an erythropoetin. These products have gone through an approval process in their home countries, but as they have not gone through the European pathway, they are not formally classified by IMS as biosimilars. Locally-developed products such as these slow penetration of original biologics in pharmerging markets, but raise overall volume use of biologics as they are generally less expensive. Although we predict future growth may be driven by these biosimilar-type products rather than by original biologics, in a region where oncologics, antidiabetics and anti-rheumatics (core biologic product areas) are some of the fastest growing therapy areas, there is little doubt that pharmerging markets will be a source of future biologics growth.
The impact of biosimilars on the market
At present the penetration of biosimilars is very low, representing just 1% of the biologics market in value terms. Uptake in Europe has been variable, both by therapeutic market and country, and in the US there is not as yet a regulatory pathway to approve these products. However in March 2010, US lawmakers passed legislation to promote competition in the biologics market: the Biologics Price Competition and Innovation Act permits the approval and marketing of follow-on biologic drugs in the US. Entry of biosimilar therapies in the US market is therefore expected from 2014, when the legislative pathway is expected to be in place. Uptake is then predicted to accelerate, as availability of biosimilars in the US will coincide with the end of the current window of major small-molecule loss of exclusivities, meaning payers will have to look elsewhere to continue to realise cost savings. With many of the current top-selling biologics losing product patent protection over the next five years (Enbrel in 2012, Mabthera 2013, Remicade 2014, Herceptin 2015), there has been a scramble for early market entry and market leadership within the biosimilars world. SM generics are traditionally led by generic specialists such as Sandoz and Teva. But although these companies were early entrants and are strong in biosimilars, big pharma are also hungry for a piece of the pie. Merck, Pfizer and BI have all announced their intention to play in the biosimilars field [9-11]. There is of course much speculation about the success of the biosimilars market and the impact it will have on forward movement in the entire biologics market. But with the stagnant growth seen in SM pharmaceuticals and increasingly crowded therapy
areas in the biological space leading to diminishing returns, biosimilar markets offer an attractive opportunity for diversification in a higher margin market.
Expansion, but a tougher market
In the short term, biologics are expected to outpace overall pharma growth, with a forecast CAGR of 7.7% from 2010-2015. Growth is expected to slow from 2015-2020 as biosimilars enter the US market. IMS conservatively forecasts the market could be worth US$253bn by 2020 – almost double its present value. IMS also foresees that even though biologics are entering a tougher era – with lower market growth than there has been over the last ten years – expansion outside of the core biologic therapy areas, growth in the pharmerging markets and the increased uptake of biosimilars will make this an exciting and rewarding sector over the coming decade.
References  IMS Midas June 2011; excludes discounts and rebates  European Medicines Agency, Human Medicines Overview  FDA Orphan Designated and or Approved Products database  IMS Lifecycle: R&D Focus  NIH Clinical Trials Service; www.clinicaltrials.gov  Dr Reddy’s, http://www.drreddys.com/products/popups/reditux.htm  Hayao Group, http://www.hayao.com/Corporation/major.asp?cInfoId=195&dInfoId=262  “Biologics Price Competition and Innovation Act”, 2010 http://dpc.senate.gov/healthreformbill/healthbill70.pdf  Merck 2008 Annual Report  Ahmed, R., Becker, N., “Pfizer, Biocon in insulin licensing deal,” Wall Street Journal, October 2010  “Boehringer Ingelheim expands its Business with Biosimilars”, BI Press Releases, September 2011
Contact Carolyn Gauntlett, PhD Consultant, Thought Leadership – IMS Health 7 Harewood Avenue, London NW1 6JB CGauntlett@uk.imshealth.com www.imshealth.com
Until a decade ago, the United States was the undisputed leader in bioscience industry development. Global competition within the industry has dramatically increased – fueled in large part by low-cost labor, the speed of...
Until a decade ago, the United States was the undisputed leader in bioscience industry development. Global competition within the industry has dramatically increased – fueled in large part by low-cost labor, the speed of information dissemination, and available risk capital. In the United States, local and national government leaders continue to understand this new dynamic of increased competition for developing the biosciences and are actively working to expand and promote industry growth.
Nearly every competitor in this increasingly global economy has access to big breakthroughs in technology and to the equipment and capital to produce standardized products, but those regions that possess the human capital – with its insights, competencies, and experience – will have the competitive advantage. As the United States has adjusted to accommodate increased global competition, within this and other industry sectors, state and regional leaders have also sought to attract and retain high-wage, high-skilled jobs that offer the most promise to cure disease, feed the hungry, clean our environment and provide renewable sources of energy. Biotech jobs and salaries within the United States have substantially grown in the past ten years. To date, there are more than 47,000 bioscience companies and 1.4 million workers across 50 states and Puerto Rico. Moreover, the industry has grown an average 3.5% each year during the past decade. Even during this deep recession, our industry actually grew between 2009 and 2010, though in uneven numbers depending on the sector. While total private sector employment was down by 6.2% in 2009, total bioscience employment was actually up by 2.8% in that year. And biotech workers in the United States earn on average more than US$77,000 per year, significantly higher than the national average of over US$45,000 for all private industries. Beyond the statistics, the bioscience industry has come into play in the economic development initiative of states, cities and municipalities for several important strategic reasons. First, we are a vital component of the durable goods manufacturing sector of the economy in an environment of increasing and sustained international competition. Many states have a strong biosciencemanufacturing presence that produces some of the highest quality products in the marketplace. Second, these are high-skill, high-wage jobs that diversify the economy and support the creation of an improved standard of living, and help boost revenues from state and local taxes to support education, public safety, and other budget priorities. This is especially important as states focus on efforts to rebound out of a major recession. Third, the industry is intertwined with technology transfer efforts of universities, workforce development at community colleges, and inflow of federal and private research grants for invention and innovation and workforce training funds to match employer needs and employee skills. In the last year alone, state legislatures in Missouri, Wisconsin, Tennessee and Colorado have passed bills that reinvest tax dollars in bioscience economic development initiatives. Additional examples of state legislative best practices in support of bioscience industry development are available at BIO’s website (www.bio.org). While the economic climate has been difficult for bioscience companies, it has also had a significant impact on state budgets, causing some states to cut programs and reassess economic priorities. However, almost every state in the country is actively engaged in building bioscience industry infrastructure. State-sponsored programs to encourage investment and help bioscience companies leverage existing resources can be instrumental in helping these innovative companies survive this economic cycle. Realizing the economic potential, state and regional economic development leaders throughout the nation have become much more aware of the industry’s needs, and have put numerous programs and incentives in place to attract and nurture the biosciences. These programs include: – Providing business and financial assistance to emerging companies – Creating tax and regulatory environments to support and expand growing companies – Addressing capital needs by providing funding for pre-commercialization activities – Creating seed funds – Implementing policies encouraging private investment in early and later state venture capital – Supplying capital for facilities funding – Working closely with bioscience companies to develop and create a skilled workforce. Due in part to the international economic downturn, lawmakers have become increasingly aware of the unique challenges facing bioscience companies, such as high research costs and the long development timeline involved in bringing a new bioscience product to market. They understand the importance of a stable and supportive business industry climate for small and emerging companies. Some states are allowing companies to monetize earned R&D and net operating loss credits, sales tax exemptions for the purchase of R&D equipment, and investment tax credits to drive angel capital investment in the bioscience industry. American ingenuity is perhaps our greatest intangible resource. Exciting discoveries are often made in our university laboratories. Most of these discoveries are early stage and require lengthy R&D, which requires a massive infusion of private capital. Moving that intellectual property into the marketplace is a continuing challenge. There is, after all, no guarantee that these initial discoveries will ever lead to safe, effective, and commercially viable products. The US Food & Drug Administration (FDA) has the critical mission of reviewing new drugs (and other medical products) for safety and efficacy. However, the FDA’s regulatory processes have not kept up with rapidly advancing science, slowing the delivery of cures and breakthrough medicines to patients who desperately need them and creating uncertainty that impedes the ability of biotech companies to obtain the funding required for continued innovation. BIO is advocating for full funding for the FDA, for the reforms necessary to ensure the agency has the ability and resources it needs to renew its focus on reviewing products in a timely manner, and for a consistent and science-based decision-making process that reflects patient needs. The severe economic downturn makes it difficult to focus on issues beyond the short-term imperative of improving our economic footing and reversing the deep declines in jobs. But just beyond today’s economic ups and downs are warning signs that the United States is slipping in generating the skilled, educated workers needed to meet the demands for a highly trained, technical workforce in today’s knowledge-based economy. Our struggle to attract and retain a continuing flow of educated (Ph.D., MS, BS, AA) and technically-proficient workers is a growing concern. Regrettably, our country is failing to prepare students for pursuing biosciences in higher education – a key pipeline for developing the bioscience workforce of the future. And finally, the U.S. Congress, a majority of the states, and numerous organizations continue to debate reform of The Patient Protection and Affordable Care Act, the sweeping overhaul of the nation’s healthcare system. The law includes provisions to create a pathway for the approval of follow-on biotechnology medicines, and a US$1bn therapeutic discovery tax credit, both of which were widely supported by the bioscience industry. Bioscience development is not simply about generating economic returns. The great promise of the biosciences is the ability to address global problems – from human health to food generation, from security to environmental sustainability and clean energy. Bioscience development pays huge social and quality-of-life dividends for the US and the world. State and federal fiscal woes threaten the United States’ leadership in basic research. The recent recession and its impact on capital markets have created a very sharp decline in venture capital for bioscience companies, which is critical to advancing bioscience innovation into the marketplace. And, in the long-term, the talent pipeline in the biosciences remains an area of significant concern. State and national policymakers have a key role to play in ensuring that these challenges are addressed in order to allow the United States to continue to be a world leader in the biosciences.
London – The EMA has proposed revising its guidelines for biosimilar products. In mid-November the Agency said that the current “conceptual” guidelines – which date back to 2005, when no biosimilar products were marketed in the...
London – The EMA has proposed revising its guidelines for biosimilar products. In mid-November the Agency said that the current “conceptual” guidelines – which date back to 2005, when no biosimilar products were marketed in the EU – no longer seem appropriate in light of the experiences it has now had with a large number of MAAs and in consultations with applicants. In a paper due to be released by February 2012, the Agency states that: – the principles of biosimilarity may have to be explained in a clearer way. – the term “biosimilar” has been used in an inappropriate way. – a discussion on feasibility for following the generic legal basis for some biological products needs to take place. – some specific aspects need to be discussed again and potentially refined. According to the Agency, the focus of biosimilar development programmes today is to establish similarity to the reference product, not clinical benefit. Consequently, an update of the guideline should make this principle – and its consequences – clearer to the reader. In this light, the EMA proposes discussing the equivalence of efficacy and safety aspects, if not covered by the revision of the general non-clinical and clinical guideline. According to the guidelines from 2005, a substance’s pharmaceutical form, strength and route of administration should be the same for the biosimilar and the reference medicinal product. But now the Agency says talks must take place on whether providing additional data in case of non-comparability is realistic. Finally the current guideline provides a long list of references, including outdated ones. The Agency wants to discuss whether these references should also be changed and updated, given the fact that many more biosimilar-related guidelines have been drafted since 2005.
Denmark’s tradition of successful pharmaceutical companies and clinical trials stretches back more than a century, and over the past decade the country has emerged as a major global player in the field of biotech research.Denmark...
Denmark’s tradition of successful pharmaceutical companies and clinical trials stretches back more than a century, and over the past decade the country has emerged as a major global player in the field of biotech research.
Denmark is currently home to one of Europe’s strongest life sciences clusters, which employs some 42,000 specialised experts in an industry composed of more than 160 biotech companies and more than 20 clinical research organisations. Additionally, more than 5,000 life sciences students graduate annually from eight universities and four major university hospitals in the Danish life sciences cluster. Close collaboration between Danish academia, industry and public health institutions has led to strong academic track records and industry solutions. With more than 230 drug candidates in preclinical and clinical development in 2011, Denmark has the third largest commercial drug development pipeline in Europe in terms of absolute numbers according to a 2011 Ernst & Young report. That strong pipeline is backed up by a proven ability to take drug candidates into preclinical and clinical development (Science 2010, Vol. 327, issue 5963).
The address of one of Europe’s most successful clusters
The Danish life sciences cluster is spearheaded by Medicon Valley, one of Europe’s strongest life sciences regions. It comprises a dense conglomeration of universities, hospitals and companies located in the eastern part of Denmark and the southern area of Sweden. The importance of having a strong biotech cluster has become particularly obvious throughout the current financial crisis. Medicon Valley has helped the country remain attractive to both investors and knowledge-intensive talent. That has in turn allowed Denmark to maintain its leading position in the field of biotechnology, despite unrest on the markets and the current lack of funds in general in the sector. Another reason for the success is that many Danish biotech companies have chosen to pursue a long-term financial strategy. One aspect of that forward-looking planning is that many companies realised funds and investments when they became available, rather than waiting until circumstances or need forced them to do so. This strategic approach prepared Danish biotech companies for the new leaner era, leaving them less susceptible to pressure when it comes to delivering results within certain time-frames – the fate of many of their foreign competitors.
Denmark – a major exporter of pharmaceutical products
Danish pharmaceutical product exports saw growth of 23% in 2010 despite the ongoing financial crisis, which is an important indicator of the Danish life sciences cluster’s ability to weather the economic storm. Danish biotech and pharmaceutical exports are the biggest export sector in the country, and when the field as a whole profits, it benefits the Danish life sciences cluster overall, since capital is often reinvested in new projects and businesses. Because of the sector’s significance, the biotech and pharma industry also has a high political profile in Denmark. In terms of government policy, it is important that the general life sciences sector is not only doing well, but is also provided with the conditions for conducting solid research and development.
Denmark excels in translational research & personalised medicine
One big advantage of a small country is that networking is easier than in a large one, with less psychological and physical distance between the scientist or scientific entrepreneur and decisionmakers such as government ministers, policymakers, and industry leaders. It also facilitates the connection between academia and industry, which is a big benefit for those professionals in translational medicine who are endeavouring to turn basic research into clinical applications. And it of course provides a big boost to research in personalised medicine overall. Denmark particularly excels in this new field of translational research, and not just because of the ease of communication between scientists in labs, researchers in industry, and clinicians in hospitals, but also due to a history of such collaborations dating back well over a century – long before the term ‘translational’ moved into common parlance. Denmark’s commitment to a knowledge economy is clear. Despite the challenging economic conditions encountered at the end of this first decade of the 21st century, our country is determined to stay on track with its pledge to boost spending on R&D to 3% of GDP. Training programmes for PhD candidates are being expanded, including a special one for industrial PhDs that focuses on both the academic and commercial sides of science. A large number of domestic funding programs – such as the country’s Innovation Consortia programme – are also in place to fund research and development in new technologies and therapies. This commitment sends a clear message to local scientists, as well as those working internationally and considering Denmark as a destination: we are serious about science, as well as about supporting key collaborations between academia and industry.
7th Berlin Conference on IP in Life Sciences: Big Data, Big Drugs
The health care industry faces significant transformation, driven by a boom in knowledge within biomedical sciences and breakthrough technologies such as gene sequencing. The management of "big data“ will change the understanding of diseases, development of drugs and treatment of patients. more