Nelson Quoted on Current State of Biosimilar Patent Litigation and Regulatory Proceedings

Biosimilars Review & Report
Partner Kevin Nelson shared his insight on the current state of biosimilar patent litigation and regulatory proceedings, and new challenges facing drug manufacturers in bringing biosimilar products to market.

According to Kevin, while settlements have impacted litigation, another reason for the slowdown in litigation activity may be related to the business case for biosimilars.

Kevin said, “Biosimilar manufacturers are concerned about the payment and reimbursement of biosimilars. Most biologics are reimbursed under Medicare Part B, and under that scheme there is more of an incentive to administer a higher-cost product, which is the established biologic and not the biosimilar.”

Manufacturers are also being influenced by new legislation and regulatory policies, such as the Inflation Reduction Act (IRA). “Manufacturers are unsure of what the exact impact of the Inflation Reduction Act will be on the payment for biosimilars,” Kevin said. “The Act purportedly seeks to keep the costs of biologic and biosimilar costs down and ensure high reimbursement payments, but many are skeptical and even believe prices will increase."

He noted however that competition is still coming primarily from the same sources as in the past.

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