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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.

Regulation Generic Drugs

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.

Biosimilars Approvals

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.

Europe Approvals

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.

Biosimilars Regulation
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