New EU Filings
Natalizumab, Polpharma Biologics’ proposed biosimilar to Biogen’s Tysabri for treating relapsing-remitting multiple sclerosis, is among the latest medicines that have been submitted for review for potential pan-EU approval.
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The European Medicines Agency has begun reviewing a new batch of EU marketing authorization applications.
Polyhexanide, from SIFI, could become the first approved treatment for acanthamoeba keratitis, while aflibercept could become the first biosimilar version of Eylea in the EU.
The sponsors of two monoclonal antibody products, tislelizumab and tremelimumab, are each seeking marketing approval for more than one indication.