The Center for Biosimilars® recaps the top news for the week of October 8, 2018.
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.