- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilars Articles for the Week of September 4
The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 4, 2017.
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 September 4.
Number 5: A recent analysis shows that biologic agents represent the highest single cost associated with infusion therapy for rheumatoid arthritis patients.
Number 4: Drug maker USV announced that it has successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar. The company expects to submit data to the European Medicines Agency before the end of the year.
Number 3: The European Association of Hospital Pharmacists recently released a position paper on biosimilar medicines. The paper contains marked contrasts to the FDA’s current thinking about biosimilars in the United States.
Number 2: This week, state governors and insurance commissioners testified before the US Health, Education, Labor, and Pensions Committee on stabilizing the Affordable Care Act marketplace.
Number 1: Drug maker Celltrion has received the FDA’s Form 483 after a recent inspection of its manufacturing facility. The form notes 12 observations that include problems with vial stoppers of injectable drugs and visible particulate in products.
Finally, last week, our newsletter asked you to share your thoughts about whether the FDA’s recent approval of a second adalimumab biosimilar is likely to influence prescribing behavior. To view results of the poll, visit The Center for Biosimilars® 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.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
