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The Top 5 Biosimilar Articles for the Week of February 28
Here are the top 5 biosimilar articles for the week of February 28, 2022.
Hi, I’m Skylar Jeremias 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 February 28, 2022.
Number 5: A report from the National Alliance of Healthcare Purchaser Coalitions detailed the common concerns employers have regarding implementing biosimilars within their health care plans and outlined how they could take charge and make a difference.
Number 4: Switching patients with Crohn disease from reference adalimumab to SB5, a Samsung Bioepis biosimilar, did not lead to major changes in disease activity in a real-world analysis.
Number 3: There remains risk in the US market due to regulatory and legal hurdles—not to mention a combative political environment, said executives during the “CEOs Unplugged” session at Access! 2022, held by the Association for Accessible Medicines (AAM) in Orlando.
Number 2: Prestige BioPharma has announced that the manufacturing facility for Tuznue, a proposed trastuzumab biosimilar, has received European Union (EU) Good Manufacturing Practices (GMP) certification.
Number 1: The FDA has accepted biologics license applications (BLAs) for interchangeability status from Alvotech and Pfizer regarding their respective adalimumab biosimilars referencing Humira.
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.
