One In Five New EU Filings Are For Biosimilars
The European Medicines Agency received 17 filings for biosimilar medicines last year, accounting for 18% of all centralized marketing authorization applications. As of April 2018, the EMA had received a total of 77 biosimilar MAAs. Scientific advice is also proving popular with biosimilar developers, and the agency has been upping its communications to stakeholders such as healthcare professionals and the public.
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The EMA’s CHMP has adopted positive opinions on two more biosimilar products: trastuzumab and infliximab. Sixteen biosimilars remain under review at the agency.
Monoclonal antibody developers are showing interest in the European Medicines Agency’s pilot project that is offering bespoke scientific advice on biosimilars.
COVID-19 and Brexit have put a great strain on the resources of the EU medicines regulatory system, but the planned review of the EU fee system could produce a system that is more flexible, efficient and better able to respond rapidly to emerging technologies and the needs of health care systems, says EFPIA.