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The Top 5 Biosimilars Articles for the Week of July 13
Here are the top 5 biosimilars articles for the week of July 13, 2020.
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 biosimilars articles for the week of July 13, 2020.
Number 5: Biocon is planning to list its biosimilar entity, Biocon Biologics, on the capital markets in the next few years. Although this move will allow the entity to expand on current projects, it also raises questions about whether it will be successful.
Number 4: A monoclonal antibody from Biocon Biologics of Bengaluru, India, has been approved by the Drugs Controller General of India for the emergency treatment of acute respiratory distress syndrome (ARDS) in patients with coronavirus disease 2019 (COVID-19).
Number 3: Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, according to columnist Sarfaraz Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the College of Pharmacy at the University of Illinois at Chicago.
Number 2: The FDA has approved an adalimumab biosimilar (Hulio) from Fujifilm Kyowa Kirin Biologics, making it the sixth adalimumab biosimilar to AbbVie’s reference product Humira that has been approved and the 28th biosimilar approved by the FDA. Mylan will be handling the commercialization in the United States.
Number 1: Byoungseo Choi, head of marketing for Celltrion Healthcare, discusses how Celltrion's infliximab biosimilar can aid in the treatment of COVID-19—related inflammation, as well as the company’s launch plans for biosimilars through 2030.
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.
