Polpharma SA
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Latest From Polpharma SA
European Regulator Pulls Marketing Authorizations For Tecfidera Generics
In a blow to several generics firms – albeit one telegraphed by a decision handed down nine months ago – the European Commission has ordered the removal of marketing authorizations for generic versions of Biogen’s MS brand, Tecfidera.
Formycon Announces Health Canada Approval Of Ranibizumab Biosimilar
Formycon has announced the approval of its biosimilar ranibizumab by Health Canada, with commercial launch by Teva expected to begin in Q1 next year.
EMA Says Yes To Janssen’s Talvey & 13 Other Drugs
Fourteen new products could be approved in the EU soon, after the European Medicines Agency gave them the thumbs up.
Triple Threat: EMA Endorses Three First-Time Biosimilars
At an eventful European Medicines Agency committee meeting in July, three biosimilars from Biocon, Sandoz and Fresenius Kabi have become the first for each respective molecule – aflibercept, natalizumab and tocilizumab – to gain the endorsement of the CHMP.
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