Here are the top 5 biosimilar articles for the week of February 21, 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 21, 2022.
Number 5: In a 50-46 vote, the Senate confirmed Robert Califf, MD, as President Biden’s FDA commissioner. The agency has been without a permanent leader for more than a year.
Number 4: A report from AHIP found 3 drugs that have multiple biosimilars available can be delivered more affordably through specialty pharmacies.
Number 3: A panel of experts detailed the current concerns regarding interchangeability designations for biosimilars in the United States and calls for regulators and policy makers to make changes to allow for easier access to biosimilars and greater adoption.
Number 2: Iceland’s national health plan required patients to switch from Humira to the Samsung Bioepis biosimilar, Imraldi, which had a different injection device and contained citrate, a chemical buffer used to maintain the medication’s stability.
Number 1: Selexis and Generium launched an omalizumab biosimilar on the Russian market; Remsima sales hit a record high for Celltrion Healthcare; Xbrane Biopharma shares long-term results for its ranibizumab biosimilar.
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.