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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.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.
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.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
