Biosimilars Forum Warns Limited Negotiation Policies Will Stymie Innovation

Forum Supports Robust Free-Market Competition as the Solution to Lowering Drug Costs

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement supporting a robust biosimilars market. Members of the Biosimilars Forum not only represent the pioneers and leaders of the biosimilars industry, but they are also leaders in pharmaceutical innovation and generic medicines. The Forum’s 10 member companies support patients by developing innovative treatments and supporting robust free market competition as the solution to lowering drug costs.

“The Biosimilars Forum is grateful for the work the Senate has done to support biosimilars, and we appreciate that pro-biosimilars policies, such as ASP+8%, made it into the bill. With 36 biosimilars approved and 22 on the market today, ASP +8% will help improve the adoption of biosimilars.

“However, there are issues that we will need to continue to fix in order to support a long-term competitive biosimilars marketplace. Unfortunately, taken as a whole, the legislation lays out a narrowly-focused policy on negotiation that will damage the biosimilars pipeline and impair the growth of the industry.

“Negotiation is a limited and short-term solution – especially when compared to the long-term, sustainable, free market competition that biosimilars provide. The Forum supports a free market approach to lowering drug costs that drives innovation. Robust free-market competition is the solution to lowering drug costs. Alternately, prioritizing price negotiations will stymie American bioscience innovation and prevent patients from accessing the treatments they need.

“Much more must be done to support biosimilars. Biosimilar development is a lengthy and costly process. This legislation does not provide adequate support for this unique process and the need for predictability when developing biosimilars. While the Forum greatly appreciates the efforts of our champions to secure a two-year delay for future biosimilars, this timeline is not enough to guarantee that the biosimilar industry is successful moving forward. We will work with our supporters in Congress to strengthen this bill and advance additional policies that will secure the future of the biosimilars industry.

“We stand ready to work with the Biden Administration, policymakers on both sides of the aisle, and federal regulators to ensure Americans have access to biosimilars now and in the future. The Forum’s goal is to achieve real, long-term cost savings. We look forward to rolling up our sleeves to achieve meaningful progress on improving the biosimilars provisions of this bill and advancing common sense policies that support biosimilar competition such as shared savings models, a biosimilars zero-dollar copay program to eliminate a patient’s out-of-pocket cost under Medicare Part B, FDA user fees, intellectual property fixes, robust biosimilar formulary access under Medicare Part D, and other priorities.

“The Biosimilars Forum supports a competitive market environment that enables safe, effective, and lower-cost biosimilars and innovation to thrive. We believe policies should support patients and providers by enabling fair access to all pharmaceuticals across all policies.”

For more information on the Biosimilars Forum’s work to increase access to lower-cost biosimilars, visit biosimilarsforum.org.