The Center for Biosimilars® recaps the top news for the week of November 5, 2018.
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 November 5.
Number 5: Oncobiologics has announced that it has dosed the first patients with wet age-related macular degeneration in a clinical trial of ONS-5010, an ophthalmic bevacizumab candidate.
Number 4: Three attorneys from Goodwin hosted a webinar this week to provide updates on topics ranging from the Biologics Price Competition and Innovation Act Litigation, the Patent Trial and Appeal Board, and recent regulatory and FDA issues related to biosimilars.
Number 3: Regeneron posted positive third quarter earnings results for 2018 that show aflibercept sales in the United States increased 7 percent to 1.02 billion dollars versus third quarter 2017 results.
Number 2: Momenta Pharmaceuticals recently announced that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.
Number 1: Sandoz announced this week that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013.
Finally, last week, our e-newsletter asked if the eventual approval of upadacitinib could curb the uptake of biosimilar infliximab.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
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.