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The evolving biosimilars market

Safety and efficacy doubts remain a challenge

Laurent ChanrouxThe biosimilar market has continued to evolve rapidly in 2015, with the EMA's revised overarching guidelines on biosimilars coming into force and the FDA's approval of biosimilar filgrastim through the new biosimilars pathway (established under the Biologics Price Competition and Innovation Act).

Although these key regulatory developments are expected to greatly facilitate the approval of biosimilars in the near future, recent research from Research Partnership's Therapy Watch revealed that only 47% of rheumatologists interviewed would prescribe a biosimilar within the next six months, and that these agents might eventually only account for 12% of their biologic patients.

Our panel also highlighted the continued need for biosimilar manufacturers to address the remaining doubts about the safety and efficacy of these drugs and work with regulatory agencies and physician organisations to address the lack of clear treatment guidelines governing their use.

Laurent Chanroux

Laurentc@researchpartnership.com
+44 (0)20 8069 5016

21st July 2015

From: Marketing

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