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The Top 5 Biosimilars Articles for the Week of October 30
The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 30.
Transcript:
Hi, I’m Laura Joszt 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 October 30.
Number 5: The FDA has announced that it will recognize 8 European regulatory agencies as capable of conducting manufacturing facilities inspections that will meet FDA requirements.
Number 4: More than 90% of Americans believe that the cost burden of cancer is too high, according to a nationally representative survey conducted on behalf of the American Society of Clinical Oncology.
Number 3: A New York union has filed an antitrust lawsuit against Johnson & Johnson, alleging that the maker of the reference infliximab has engaged in anti-competitive practices to keep biosimilar competition at bay.
Number 2: Biosimilar developers Momenta and Mylan announced this week that M834, a proposed biosimilar of Orencia, did not meet its primary pharmacokinetic endpoints in a phase 1 study.
Number 1: 54-week results of a phase 3 study in patients with Crohn’s disease support the long-term effectiveness of treatment with the infliximab biosimilar CT-P13.
Finally, this week, The Center for Biosimilars® launched a new Peer ExchangeTM, titled "Regulation, Policy, and Litigation in Biosimilars." Follow the series to hear insights on the state of biosimilars from the clinical, legal, and product developer perspectives.
To read all of these articles and more, visit centerforbiosimilars.com.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
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.
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.
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.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
