01.10.2012 - The European Medicines Association has changed its biosimilars guidelines to make it easier to develop biologic follow-on drugs in both the US and Europe.
The London-based agency said it intends to accept batches of reference medicines sourced from outside the European Economic Area (EEA) in the future. This aims to facilitate the global development of biosimilars and avoid the unnecessary repetition of clinical trials.
Under the current European legal framework, companies developing a biosimilar medicine are required to identify a reference medicine that is or has been authorised in the European Economic Area (EEA) and whose batches are sourced from within the EEA. With the new approach, first announced by Commissioner John Dalli in Malta on 15 June 2012, the Agency will begin to accept reference medicine batches sourced from outside the EEA in certain pre-clinical and clinical studies in the comparability exercise.
A draft version of the new guidance is expectedearly next year. Since biosimilars became reality, EMA has become regardedas the most biosimilar-open agency in one of the biggest pharma markets.
16.12.2014 Two consortia combined of 144 European companies, research institutes and universities have been selected for funding by the EIT in the areas of health and raw materials. Both clusters are set to acquire €1.1bn over the next seven years.
10.12.2014 When it comes to the biggest investors in Research and Development (R&D) Swiss pharma top dogs Novartis and Roche have defended their positioning among the top ten companies worldwide – according to a recently published EU study.
05.12.2014 Austrian contract research company VTU has entered into a development and commercialisation agreement with US company RCT. The partners want to combine both companies' Pichia pastoris protein production technologies under VTU's roof.
03.12.2014 Danish biotech pharma Ascendis has successfully completed a €48m Series D financing round. The funding is expected to support its late-stage clinical trials to push its lead drug into Phase III trials.
01.12.2014 In spite of innovative new medicines on the market, the UK and Germany lag behind other countries and continue to use older medicines - especially in the treatment of cancer. French and Spanish patients, on the other hand, benefit much earlier from medical innovation.
28.11.2014 The first gene therapy for a rare genetic condition — UniQure's Glybera — is on its way to the European market. But there is a hefty price tag: Chiesi, responsible for the marketing of the orphan drug, is asking for a record price of €1.1m per patient.