The Center for Biosimilars® recaps the top news for the week of August 20, 2018.
Transcript:
Hi, I’m Samantha DiGrande 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 biosimilars articles for the week of August 20.
Number 5: A Japanese company has launched Celltrion’s trastuzumab biosimilar in Japan, but the product will only be sold to treat HER2-positive gastric cancers.
Number 4: The FDA has granted priority review for Alexion’s proposed long-acting C5 complement inhibitor that could help stave off biosimilar competition for the Soliris market.
Number 3: A new paper in BioDrugs argues that phase 3 studies may no longer be necessary for biosimilars.
Number 2: The United Kingdom’s National Institute for Health and Care Excellence says that it does not recommend Perjeta for routine use after surgery in patients with breast cancer, even though using the drug in combination with biosimilar trastuzumab could reduce the total cost of treatment.
Number 1: Pfizer’s proposed adalimumab biosimilar demonstrated similar efficacy, safety, and immunogenicity profiles to the reference Humira at 26 weeks of treatment in patients with rheumatoid arthritis.
Finally, last week, our e-newsletter asked whether you think that the United States’ patent system needs reform to prevent abuse by drug makers.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.