The Biosimilars Forum Welcomes Bipartisan Legislation to Strengthen Biosimilar Competition

Biosimilars Are a Key Solution to the Prescription Drug Affordability Crisis, and This Legislation Would Help Ensure Lower-Cost Biosimilars Reach Patients

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after bipartisan legislation (H.R.10628 and S.5571) was introduced in the House of Representatives and the Senate that would help strengthen biosimilar competition and lower costs for prescription drugs.

“The Biosimilars Forum and our members welcome the two pieces of important legislation to address industry concerns about when biosimilars are eligible for price negotiations under the Medicare program. This is an important step in the right direction in making biosimilars more readily available and accessible to patients. This legislation can provide the clarity and predictability biosimilar developers need to plan the investments that bring lower-cost medicines to patients.

“The House bill has eight bipartisan co-sponsors: Reps. John Joyce (R-Pa.), Rudy Yakym (R-Ind.), Nathaniel Moran (R-Texas), Jake Auchincloss (D-Mass.), Linda Sánchez (D-Calif.), Scott Peters (D-Calif.), Kevin Mullin (D-Calif.) and Jimmy Panetta (D-Calif.). In the Senate, Senators Marsha Blackburn (R-Tenn.), Ted Budd (R-N.C.), James Lankford (R-Okla.), and Adam Schiff (D-Calif.) introduced companion legislation. The Forum thanks these leaders for their work on this issue and their bipartisan commitment to lower-cost biosimilars. Their efforts can help bring more biosimilars to the market more quickly, ensure those biosimilars can reach patients, and lower everyday healthcare costs for Americans. I also thank the members of the Biosimilars Forum, whose companies are dedicated to providing patients with the safe, effective, lower-cost medicines they need.

“While this legislation is good progress in ensuring more biosimilars can reach patients, more must be done to ensure the promise of biosimilars is fully realized. When companies can confidently invest in biosimilar development, patients and the healthcare system will benefit from more competition, greater choice and lower prescription drug costs.

“Biosimilars are a proven source of competition that can lower costs and expand treatment options for patients. But developing a biosimilar is a lengthy and costly process. The average time for the first biosimilar to launch is 18 years, and the earliest a biosimilar has ever entered the market is just under 13 years. Developing a biosimilar can take up to nine years and $300 million, and those investment decisions are made years before a manufacturer can know whether the reference product will be selected for negotiation.

“Ensuring biosimilars reach the patients is especially important considering the ‘biosimilar void.’ Of the 118 biologics expected to lose patent protection over the next decade, only 10 percent currently have biosimilars in development. This void in the biosimilar market significantly limits potential savings to the healthcare system, and steps to streamline development and approval can help mitigate its detrimental impact on the industry.

“Nearly 30% of Americans say they have not taken their medication as prescribed due to unaffordable prices. FDA-approved biosimilars are on average more than 50% lower-cost than the originator biologics they reference. Biosimilars are a key component of the solution to fix America’s healthcare affordability crisis. 

“Today, nearly 90 biosimilars have been approved by the FDA in the United States across dozens of disease states. The potential of biosimilars is enormous. To date, biosimilars have been associated with savings of $56 billion, but with support from the Administration and Congress, this number can be much higher. In fact, the next five years could see an increase in savings up to $181 billion for Americans and the healthcare system. 

“The Biosimilars Forum looks forward to working with the bill’s sponsors, Congress, and the Administration to move it forward and to ensure the IRA supports, rather than undermines, biosimilar competition.”

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

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