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Biologics Legislation Is Headed to Biden's Desk for Signature


US senators hope to spread the word about biosimilars and limit product exclusivity protections to those products that truly deserve them.

Two pieces of legislation with the potential to improve biosimilar uptake are headed to President Joe Biden’s desk for his signature, following approvals in the House and Senate. Biosimilars are competitors’ versions of originator drugs and generally enter the market at a discount, offering hope for savings.

The Advancing Education on Biosimilars Act would require more robust federal efforts to educate the public about biosimilars, and the Ensuring Innovation Act would impose more restrictions on what biologics and generics drugs qualify for product exclusivity protections.

Education bill cosponsor Senator Maggie Hassan, D-New Hampshire, has described biosimilars as an “under the radar alternative to expensive brand name drugs.” Hassan and cosponsor Senator Bill Cassidy, MD, R-Louisiana, say the bill is expected to help improve confidence in biosimilars and lead to increased use and savings.

The Biosimilars Forum, a trade group representing manufacturers of biosimilars, indicated it favors passage of the education legislation. “The FDA has identified education as an important factor for the successful adoption of biosimilars, recognizing the need to increase public awareness in the Biosimilars Action Plan, and increased education can empower physicians and patients,” said the group’s executive director, Meaghan Rose Smith, in a statement.

The Ensuring Innovation Act is designed to close loopholes that allow companies to achieve patent protections for drugs that do not represent true innovations.

For more reading on the Advancing Education on Biosimilars Act, click here.

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