- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilars Articles for the Week of January 15
The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 15, 2018.
Transcript:
Hi, I’m Kelly Davio 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 15.
Number 5: The United Kingdom’s Medicines and Healthcare Products Regulatory Agency announced that it will not make any sudden changes to the nation’s regulatory framework following Brexit.
Number 4: A newly published study found that pediatric patients with Crohn disease who received early combination therapy with infliximab and azathioprine had significantly increased linear growth compared with patients who received step-up therapy.
Number 3: Several European nations are amending their policies in order to create better conditions for biosimilar uptake.
Number 2: Sandoz announced that the FDA has accepted its Biologics License Application for a proposed adalimumab biosimilar.
Number 1: The Medicare Payment Advisory Commission called for changes to Medicare Part D to remove financial disincentives that block the use of lower-cost biosimilar therapies.
Finally, last week, our e-newsletter asked whether you think that Congress should revisit legislative solutions to the problem of high drug prices. To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
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.
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.
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.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
