The Center for Biosimilars® recaps the top news for the week of October 8, 2018.
Transcript:
Hi, I’m Samantha DiGrande 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 8.
Number 5: Earlier this month, the United States, Mexico, and Canada agreed upon an updated version of the North American Free Trade Agreement. Since the details of new agreement were released, the pharmaceutical intellectual property portions of the deal have come under scrutiny.
Number 4: Fresenius Kabi recently announced that its proposed pegfilgrastim biosimilar, MSB11455, met its primary endpoints in 2 clinical studies that are intended to facilitate regulatory applications for the product in the United States and European Union.
Number 3: The Association of European Cancer Leagues has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.
Number 2: Mundipharma announced this week that it has acquired Cinfa Biotech, along with its proposed biosimilar pegfilgrastim, B12019, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use last month.
Number 1: The Oncologic Drug Advisory Committee held an open public hearing this week to discuss the biologics license application for CT-P10, a proposed rituximab biosimilar. All 16 committee members voted to recommend the product to the FDA for final approval.
Finally, last week, our e-newsletter asked if states should enact laws to limit nonmedical switching.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
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How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
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.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.