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The Top 5 Biosimilar Articles for the Week of January 10
Here are the top 5 biosimilar articles for the week of January 10, 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 January 10, 2022.
Number 5: A comparative study of PanGen Biotech’s epoetin alfa biosimilar candidate PDA10 and the reference product, Retacrit, demonstrated comparable efficacy and safety.
Number 4: Concerned about patient access to monoclonal antibody medications, including biosimilars, patient advocates in India appealed to the country’s executive administration to spur reforms in biologics regulation.
Number 3: Alvotech became the second biosimilar developer to announce an approval in the Canadian market for a high-concentration, citrate-free adalimumab biosimilar (Simlandi).
Number 2: A strong market and development push for “biobetters” is anticipated by authors of a review of biosimilar and new biologic drug development in ophthalmology.
Number 1: Seeking to position themselves optimally for a share of the adalimumab (Humira) market, Samsung Bioepis and Organon are seeking FDA approval for a biosimilar high-concentration, citrate-free formulation (100 mg/mL) of adalimumab.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
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.
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.
