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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More Biosimilars Of Herceptin And Remicade Get EMA Yes
The EMA’s CHMP has adopted positive opinions on two more biosimilar products: trastuzumab and infliximab. Sixteen biosimilars remain under review at the agency.
EMA’s Pilot On Bespoke Scientific Advice For Biosimilars Attracts Monoclonal Antibody Makers
Monoclonal antibody developers are showing interest in the European Medicines Agency’s pilot project that is offering bespoke scientific advice on biosimilars.
International Regulators Focus On Omicron XBB For Monovalent COVID-19 Vaccine
A workshop led by the European Medicines Agency and the US Food and Drug Administration sought to reach alignment on adapting COVID-19 vaccines to emerging virus variants.