Here are the top 5 biosimilar articles for the week of December 14, 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 biosimilar articles for the week of December 14, 2020.
Number 5: Studies of trastuzumab biosimilars in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer have yielded significant findings, according to presentations at the 2020 San Antonio Breast Cancer Symposium.
Number 4: Investigators studying biosimilar savings and use rates in HER2-positive breast cancer observed dramatically increased usage of trastuzumab biosimilars and said payer policy appears to have contributed to higher biosimilar utilization.
Number 3: Celltrion’s high-concentration, citrate-free adalimumab biosimilar candidate (CT-P17, Yuflyma) has been recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Number 2: Sarfaraz K. Niazi, PhD, an advisory board member for The Center for Biosimilars, published an opinion piece on Boehringer Ingelheim’s recent filing of a citizen’s petition asking the FDA to change its interpretation of the term strength in the Public Health Service Act.
Number 1: Biocon Biologics and Mylan have received a positive recommendation from the EMA CHMP for the marketing approval of their biosimilar insulin aspart candidate (Kixelle) for the treatment of type 1 and type 2 diabetes.
To read all of these articles and more, visit centerforbiosimilars.com.
Real-World Study Shows Comparable Outcomes Between CT-P13, Remicade in RA
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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.
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.
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.
Survey of Clinicians: Lower Cost of Biosimilars Is the Main Driver of Treatment Choice in IBD
September 7th 2024Researchers surveyed clinicians from 63 countries and found that adalimumab and infliximab biosimilars, primarily chosen for their lower cost, are widely available and have improved access to biologic treatment in inflammatory bowel disease (IBD).