Drugs

Biosimilars Forum, PhRMA Support BsUFA 3

Both the Biosimilars Forum and Pharmaceutical Research and Manufacturers of America (PhRMA) have communicated to FDA their overall support for the BsUFA 3 biosimilars user fee agreement.

The Biosimilars Forum says that improvements to the biosimilar review program negotiated under BsUFA 3 “will help bring biosimilars to the market as efficiently as possible.” The forum’s 12/2 comment letter says it applauds the agency’s willingness to engage sponsors earlier in the development process with targeted feedback and allow for increased communication and flexibility in the later stages of development.

After praising several elements of the agreement, the forum says it is “concerned with the impact of the current inspectional backlog on FDA’s ability to meet its BsUFA 3 commitments.” The letter says data on on-time actions for original biosimilar product applications indicate that biosimilars have been more adversely affected by pandemic-related inspection issues than other types of products.

“Prolonged delays to the licensure of biosimilars can negatively impact public health by hampering patient access to many life-saving or life-altering medications via more affordable lower-cost treatment options,” the letter says. “We know FDA is actively working on this issue and we look forward to collaborating with the agency on creative solutions that balance effective oversight with patient access to biosimilars.”

In its 12/2 letter, PhRMA says BsUFA 3 will:

advance development of interchangeable biosimilar products and pilot a regulatory science program;
enhance manufacturing inspection-related communications and modernize facility assessment approaches based on Covid-19 lessons learned;
modernize FDA’s information technology infrastructure and support adoption of cloud-based technologies;
build on BsUFA 2 efforts to modernize FDA financial and staff resource management; and
include other important commitments.

“BsUFA 3 will play a critical role in improving the predictable, timely, and efficient development and regulatory review of biosimilar and interchangeable biosimilar products,” PhRMA concludes. “PhRMA fully supports both the proposed BsUFA 3 performance goals as well as a timely legislative reauthorization of BsUFA.”

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