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The Top 5 Biosimilars Articles for the Week of June 4
The Center for Biosimilars® recaps the top 5 articles for the week of June 4, 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 June 4.
Number 5: Mylan and its partner Biocon received a Complete Response Letter from the FDA for their follow-on insulin glargine referencing Lantus.
Number 4: Celltrion has reported positive results of a study of a subcutaneous formulation of its biosimilar infliximab, Inflectra, in patients with Crohn disease.
Number 3: The FDA published new draft guidance that clarifies the types of formal meetings that biosimilar applicants can hold with the agency.
Number 2: During the 2018 American Society of Clinical Oncology Annual Meeting, researchers presented on new directions in anticancer and supportive care biosimilars.
Number 1: The FDA has approved its first pegfilgrastim biosimilar, Fulphila, referencing Neulasta.
Finally, last week, our e-newsletter asked whether you that US payers should encourage greater use of biosimilars.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
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.
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
