The Biosimilars Forum Strongly Supports FDA’s BsUFA IV Agreement to Strengthen Biosimilar Development and Review

Agreement Will Help Create a More Efficient, Predictable and Science-Based Regulatory Pathway to Bring Lower-Cost Biosimilars to Patients

Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement supporting the U.S. Food and Drug Administration’s release of the Biosimilar User Fee Act (BsUFA) IV Performance Goals Letter.

“The Biosimilars Forum and our members strongly support the BsUFA IV agreement and commend FDA for advancing meaningful improvements that will make the biosimilar development and review process more efficient, predictable and transparent. An updated and streamlined FDA review program is fundamental to realizing the potential of biosimilars and building a sustainable biosimilars market.

“This is a smart, forward-looking agreement that modernizes how FDA reviews biosimilars, lowers the cost of developing them and gives manufacturers the clarity and predictability they need to invest in the next generation of lower-cost medicines. This will help more biosimilars reach patients sooner and help ensure biosimilars play an even larger role in addressing the prescription drug affordability crisis.

“The Forum thanks FDA and the negotiating teams for their work to deliver a strong agreement that prioritizes patients and free market competition. 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.

“At a time when the cost of prescription drugs is one of the top concerns for American families, BsUFA IV is a meaningful step toward addressing the affordability crisis. Developing a biosimilar remains a lengthy, complex and costly process. It 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. BsUFA IV creates a regulatory pathway that gives developers greater clarity, improves communication with FDA and eliminates unnecessary delays.

“BsUFA IV also reinforces the importance of a modern, science-based approach to biosimilar development. Advances in analytical science and the experience gained from more than a decade of biosimilar approvals provide an opportunity to streamline development without compromising FDA’s high scientific standards.

“We applaud the agreement’s focus on earlier and more consistent communication between FDA and biosimilar developers. This will reduce unnecessary review cycles and help bring down the time and cost of getting a biosimilar to market.

“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. Closing that gap is essential to solving the prescription drug affordability crisis. Every biologic without a biosimilar competitor is a missed chance to lower costs for patients.”

“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 strongly supports the BsUFA IV agreement and urges Congress to move swiftly to reauthorize the program. We look forward to working with FDA, Congress and other stakeholders to ensure the regulatory environment supports continued biosimilar investment, competition and patient access.

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

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