Here are the top 5 biosimilar articles for the week of September 11, 2023.
Hi, I’m Justina Petrullo for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilar articles for the week of September 11th, 2023.
Number 5: Switching from reference to biosimilar adalimumab was found to be safe and effective, researchers cautioned that female patients may be at higher risk of discontinuation compared with their male counterparts.
Number 4: Sarfaraz K. Niazi, PhD, reacted to CMS' list of the first 10 drugs chosen for price negotiation under the Inflation Reduction Act, including 3 biologics with no biosimilar competition.
Number 3: Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.
Number 2: An approval in Australia and positive recommendations for 2 biosimilars in Europe brought hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcased that some barriers remain.
Number 1: CVS Health Corporation launched Cordavis, a new subsidiary that will work with manufacturers to commercialize and coproduce biosimilars, beginning with an adalimumab product.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars
September 9th 2024Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Switching From Originator Etanercept to Biosimilar Version Proves Safe, Effective in RA
September 5th 2024Patients with rheumatoid arthritis who switched from the etanercept originator to a biosimilar exhibited similar disease activity and drug persistence compared with those who remained on the originator, indicating that nonmedical switching does not negatively impact treatment outcomes.
The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings
September 4th 2024A recent study highlights that although biosimilars have led to significant price reductions, originator products with sole preferred coverage strategies have maintained market share, suggesting that increased biosimilar uptake alone may not fully leverage the market's competitive and cost-saving potential.