- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilars Articles for the Week of January 29
The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 29, 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 29.
Number 5: At this week’s swearing-in ceremony for Alex Azar, the new Secretary of HHS, President Donald Trump promised that the price of prescription drugs will “come rocketing down” under Azar’s leadership.
Number 4: Celltrion, maker of the biosimilar infliximab product Inflectra, has received a new warning letter from the FDA.
Number 3: A new drug pricing forecast from the consulting company Vizient suggests that biosimilars have reached a tipping point in the US marketplace.
Number 2: The Biosimilars Council has filed an amicus brief in an ongoing case brought by Pfizer against Johnson & Johnson.
Number 1: SB3, a proposed trastuzumab biosimilar developed by Samsung Bioepis, demonstrated equivalence with Herceptin, according to a new study appearing in the Journal of Clinical Oncology.
Finally, last week, our e-newsletter asked whether the FDA should release information from Complete Response Letters. 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?
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.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
