Regulatory reforms necessary, not sufficient to revitalize biosimilars

Government policies, from IRA to MFN, pose immense challenges to biosimilars, says Samsung Bioepis regulatory, strategy head Gillian Woollett 

The Trump administration has pledged to “massively streamline” the regulatory pathway for biosimilars. If FDA follows through by eliminating the default requirement for premarket comparative efficacy trials, a move supported by many global regulators, the time and cost of biosimilar development could be cut in half, Gillian Woollett, head of regulatory strategy and policy at Samsung Bioepis Co. Ltd. told The BioCentury Show.

Scientific and regulatory impediments to the biosimilar development are more easily addressed than commercial challenges, Woollett said. There are no biosimilars in development for IP to 90% of biologics nearing loss of exclusivity. Closing that gap will require policies that drive biosimilar adoption and enable products to gain meaningful market share.

The Medicare Drug Price Negotiation Program has injected an enormous amount of uncertainty into the marketplace, making it difficult for manufacturers to invest in biosimilars development, she said.

Tariffs are a threat to an industry that depends on global supply chains to achieve efficiency and contain costs, Woollett said. Adoption of the most favored nation international reference drug pricing paradigm that President Donald Trump has proposed would “kill” the biosimilars industry, she concluded.