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Biosimilars Development In EU Could Get Easier; EC Mulls Accepting Outside Data

 
• By Faraz Kermani

Industry applauds a suggestion by a senior healthcare representative that the European Commission could re-examine the overarching guideline on biosimilars to promote global development, but growth ultimately will be determined by greater worldwide harmonization.

The European Commission has given the clearest indication yet that it is ready to consider altering its regulatory framework on biosimilar medicinal products so that comparability data may be sourced from a reference product outside the EU. This groundbreaking declaration by Nils Behrndt, deputy head of cabinet at the European Commission’s Healthcare Directorate, represents a massive boost for the global development of biosimilar medicines.

Against the backdrop of the recent development in the U.S., the EU’s potential move could see companies racing to break...

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What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

ACIP Upheaval Leaves Merck & Co. In A Lurch

 
• By Jessica Merrill and Bridget Silverman

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.