The Center for Biosimilars® recaps the top news for the week of January 28, 2019.
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 January 28.
Number 5: The UK National Health Service has issued updated information on citrates in available biosimilar adalimumab.
Number 4: In observational studies of patients who have switched treatment from a reference biologic to a biosimilar, some higher rates of discontinuation may be related to the nocebo effect.
Number 3: During the CBI’s 14th Biosimilars Summit, the head of the FDA practice at Avalere said that enabling a global reference product for biosimilars would provide global access for patients.
Number 2: Bio-Thera Solutions announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra.
Number 1: Coherus announced this week that it has become the latest biosimilar developer to settle with AbbVie, maker of brand-name adalimumab, Humira, over a proposed biosimilar. In an intellectual property twist, Coherus also announced that it has sued a rival biosimilar developer, Amgen.
Finally, last week, our e-newsletter asked if the confusion around the terms interchangeability, automatic substitution, and physician-mediated switching leads to reduced acceptance of biosimilars.
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?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
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.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
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.