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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Number 3: The FDA published new draft guidance that clarifies the types of formal meetings that biosimilar applicants can hold with the agency.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.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel
August 19th 2024CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
