EU Biosimilar Filings, Opinions And Approvals
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.
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A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.
It may not yet be approved for marketing, but UCB’s potential blockbuster psoriasis drug has already got the all-clear from NICE, the health technology body that appraises new products for use in England and Wales.
Vaccination campaigns against the coronavirus in the EU are recovering ground lost in the early days of the pandemic, although the European Commission says “we need to keep up the effort.”