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More Biosimilars Of Herceptin And Remicade Get EMA Yes

Executive Summary

The EMA’s CHMP has adopted positive opinions on two more biosimilar products: trastuzumab and infliximab. Sixteen biosimilars remain under review at the agency.

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EU Biosimilar Action: New Competitors For Remicade/Herceptin, Four More Products Await CHMP OK

Two more biosimilar medicines have been approved in the EU: Sandoz’s Zessly (infliximab) and Amgen’s Kanjinti (trastuzumab). Four other biosimilars are expecting a CHMP opinion this week, including three versions of AbbVie's Humira.

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.

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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