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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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
