As patent cliff looms, collaborations for mAB biosimilars are born


Budapest/Bad Vilbel – Hungarian drug maker Gedeon Richter plc and German STADA Arzneimittel AG have signed two separate licensing and marketing contracts to develop biosimilar versions of the monoclonal antibody drugs Rituximab and Trastuzumab.
Under the terms of the first agreement,

STADA has received non-exclusive distribution rights from Gedeon Richter for a biosimilar mimicking Roche’s blockbuster rituximab against arthritis and diverse cancers, which had European sales of around €1.15bn last year. The antibody drug copy, which is expected to hit the market at the end of 2017, will be marketed by STADA in geographical Europe and the CIS area, but not in Russia. Richter may grant one additional license to another partner in the region covered by the contract. In addition to a one digit million upfront payment, STADA will pay milestones totalling “a low double-digit million euro figure”.
Under the terms of the second contract, Richter will in-license a preclinical Trastuzumab bio­similar candidate from

STADA for a low single-digit million euro figure. STADA terminated development of the compound last year in the course of a restructuring process, and Richter said it had acquired the rights ”in order to accelerate its own ongoing development of a Trastuzumab biosimilar.” Richter says it expects clinical testing of the copycat drug to begin in two years. At that point in time, STADA will have the option to acquire a distribution license for the bio­similar, which will seek to mimic Roche’s €1.39bn blockbuster.
Experts expect the market for bio­similars to grow to US$10bn annually by 2015 as patents run out on a number of original biologicals – most of them thera­peutic antibodies.



Budapest – Mecsek Pharma has won a HUF1bn (EUR3.6m) state grant that will allow the company to test the insulin sensitiser BGT-15 in a Phase IIb clinical trial, according to Mecsek’s parent company Phylaxia Holding. BGT-15 is a...



Budapest – California-based biotech company Codexis plans to expand its expertise in fermentation technology. In August, Codexis’ CEO Alan Shaw announced that the firm will expand its activities in fermentation technology in...



Budapest – UK clinical research organisation Chiltern International Ltd has opened a new office in Budapest. The branch will be led by Dr. Attila Lorinczi , a member of the Hungarian Medical Society and the Society of Hungarian...



Budapest – The European Institute of Innovation and Technology (EIT) launched a call for proposals for its first Knowledge and Innovation Communities (KICs) at the beginning of April ( The call will remain...



Budapest/Brussels – The Budapest-based European Institute of Technology (EIT, has received its first governing board. The 18 members, who held the board’s inaugural meeting on the occasion of the EIT’s...



Debrecen/Budapest – Hungary’s leading pharmaceutical company Gedeon Richter Plc. is continuing to expand its activities in biotechnological R&D and manufacturing of therapeutic proteins. After the establishment of Richter-Helm in...



Budapest/Brussels – The European research ministers decided in mid-June that the Hungarian capital Budapest will house the headquarters of the prestigious European Institute of Technology (EIT). With a budget of EUR308m until...



Geneva – Ernesto Bertarelli, the Swiss-Italian biotech billionaire who sold his company Serono SA, has returned to the front lines of the pharma business as his new EUR1bn healthcare fund joined with Merrill Lynch to buy...



Bucharest – Three years ago, Romania was Europe’s largest cultivator of genetically modified plants (87,600 hectares of GM soy acreage). With acession, the government there had to halt the cultivation of the GM crops not approved...



Zagreb – Pliva d.d., Barr Pharmaceuticals‘ subsidiary in Croatia, is selling its three operations in Spain – Pliva Pharma Iberia, Laboratorios Edigen and Uso Racional – to Biomedica Foscama Industria Chimico-Farmaceutica. For a...

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