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A pilot project, beginning in 2017, will support the development of biosimilars.
On Dec. 16, 2016, the European Medicines Agency (EMA) announced the launch of a pilot project, scheduled to start February 2017, that will test the “value and feasibility of tailored scientific advice for the development path of biosimilar medicines.” During the project, the agency will provide biosimilar developers with advice on the conduction of studies and tests on the “basis of the quality, analytical, and functional data they have already available for the medicine.”
To obtain market authorization of biosimilars in the European Union, developers must establish similarity to the reference product. EU guidelines recommend a stepwise development of biosimilars in which required studies and tests are based on already accumulated data. The EMA pilot project will include an in-depth review of available quality, analytical, and functional data. Advice based on these data will be given to developers so they may tailor their studies and tests during development. The agency hopes this advice will be beneficial to market authorization applicants when making development strategies, but according to EMA, this advice will not be a formal pre-assessment of the data submitted.
The pilot project, which is open to any company seeking biosimilar development advice, is expected to run until six scientific advice requests have been completed. A maximum number of one request will be accepted per month. Companies interested will have a pre-submission meeting. An additional month will be added to normal scientific advice timelines so that EMA’s Scientific Advice Working Party can review the requests.