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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.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Eye on Pharma: EC Approved Ustekinumab; Zymfentra Expansion; Biosimilar Policy Briefing
September 26th 2024The European Commission (EC) approved Celltrion's ustekinumab biosimilar for chronic inflammatory diseases, Celltrion expanded access to Zymfentra (subcutaneous infliximab-dyyb) through partnerships with Cigna and Express Scripts, and the Association for Accessible Medicines held a policy briefing addressing barriers to biosimilar adoption.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The Future of Biosimilar Gene Therapies: Key Issues and Potential
September 11th 2024While biosimilars could potentially lower costs and improve access to gene therapies, significant hurdles in regulation, manufacturing, intellectual property, and market size pose challenges to their development and market entry.
