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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Sintilimab, Bevacizumab Biosimilar, HAIC Improves Survival in Patients With Unresectable HCC
April 14th 2024Positive results of sintilimab, IBI305, and hepatic arterial infusion chemotherapy (HAIC) treatment showed shrinking tumors and previously converting inoperable hepatocellular carcinoma (HCC) to resectable HCC with manageable adverse effects.