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A Bio-Balancing Act in the US

​​The FDA just released details of its Biosimilars Action Plan, with the goal of balancing innovation in drug development with timely market competition in the biologics/biosimilars market. To date the US has lagged behind the EU and Canada, in terms of both biosimilar approvals and market access. Key strategies in the plan include: (i) improve the efficiency of the biosimilar and interchangeable product development and approval process; (ii) maximize regulatory clarity for biosimilars; (iii) develop effective communications to improve patient, provider and payer understanding of biosimilars; and (iv) take new steps to address anticompetitive behaviour. They’re also looking to strengthen partnerships with regulatory authorities in Canada, Europe and Japan, and are investigating the possibility of data sharing agreements between these parties to gain better insight into the real-world efficacy and safety data of biosimilars.

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