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Sun’s Teriparatide And Multiple Aubagio Rivals Among CHMP Recommendations

Accord Healthcare And Viatris’ Mylan Receive Nods For Generics

Executive Summary

Sun’s rival to Forsteo, Accord and Mylan’s versions of Aubagio and Accord’s Nexavar generic were all endorsed by the European Medicines Agency at the CHMP’s September meeting.

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Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.

Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity

As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.

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