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.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
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.
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.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.