EU Biosimilar Filings, Opinions And Approvals
Executive Summary
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The table below shows EU regulatory developments in the biosimilars area in 2018-19. It covers new product filings with the European Medicines Agency, opinions from the EMA’s drug evaluation committee, the CHMP, and decisions on biosimilar marketing authorizations by the European Commission.
The latest update of the table, compiled on 13 January 2020, shows that five biosimilar products were approved in the EU in 2019, bringing the total number of biosimilars with an EU marketing authorization to 58 (containing a total of 15 active substances). The five products are Pfizer Inc.’s Zirabev (bevacizumab), a version of Roche’s Avastin; Fresenius Kabi AG’s Idacio and Kromeya, both versions of AbbVie’s Humira (adalimumab); and two pegfilgrastim products: Juta Pharma’s Grasustek and Mundipharma International Corp. Ltd.'s Pegfilgrastim Mundipharma.
During the year the CHMP recommended marketing authorization for five biosimilars, the latest of which was for Pfizer's Amsparity (adalimumab), a biosimilar version of AbbVie's Humira, in December 2019.
As of the beginning of 2020, 14 biosimilars were under evaluation at the CHMP, including two versions of insulin aspart (the originator is Novo Nordisk's NovoRapid/NovoLog) and two more biosimilars of bevacizumab.
The table is based on information provided by the EMA, the commission and individual companies. In the case of new product filings, the EMA gives only the substance name and the therapeutic category; other details may be provided by the company concerned on its own initiative.
The CHMP meets once a month and among other things makes recommendations on marketing authorization applications filed through the EU centralized procedure for a range of new products including biosimilar medicines. CHMP opinions are sent to the commission, which has 67 days to take a legally binding decision valid throughout the EU.