Here are the top 5 biosimilar articles for the week of August 23, 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 23, 2021.
Number 5: UnitedHealthcare (UHC) has changed its policy to indicate that the bevacizumab biosimilars Mvasi and Zirabev will not be covered in the treatment of certain ophthalmic conditions or considered ophthalmically equivalent to Avastin, the reference product.
Number 4: Rumors that HHS could calculate payment for biosimilars differently under a potential policy change have sparked concerns among providers and biosimilar developers. If the rumors are correct, the Medicare Part B payment methodology for biosimilars would be overhauled for the second time in 4 years.
Number 3: How many switches between a biosimilar and reference product will be sufficient to demonstrate that the risk of transitioning is minimal? A virtual study verified the strength of FDA guidance.
Number 2: A multicenter study of recombinant human growth hormone (rhGH) in children with Turner syndrome demonstrated safety and efficacy comparable to the reference product.
Number 1: Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggested that using the 351(a) pathway for standalone drugs and copy products may be faster and better in part 3 of a series.
To read all of these articles and more, visit centerforbiosimilars.com.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
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.