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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Monoclonal antibody developers are showing interest in the European Medicines Agency’s pilot project that is offering bespoke scientific advice on biosimilars.
New EU guidance will cover non-clinical and clinical development, trial design, endpoints, safety issues and comparators, as well as the use of immunobridging studies.