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.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.