Here are the top 5 biosimilar articles for the week of August 2, 2021.
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 August 2, 2021.
Number 5: BioFactura said it initiated a phase 1 clinical trial for its ustekinumab biosimilar candidate (BFI-751), referencing Janssen Biotech’s blockbuster product Stelara.
Number 4: Pfizer reported strong sales for its biosimilars portfolio, but these were eclipsed by the massive success of the company's messenger RNA (mRNA) vaccine for COVID-19.
Number 3: The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explained.
Number 2: Sarfaraz K. Niazi, PhD, discussed the regulatory approval of future mRNA vaccines, which will likely face fewer patent issues and are easy to replicate.
Number 1: The FDA approved Biocon Biologic's Semglee, an insulin glargine product, as the first interchangeable biosimilar, which is hoped to bring down the high cost of insulin.
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.