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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.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
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.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors
March 11th 2025The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.
