Regulatory - Page 2

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.
On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.
The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade.
The Center for Biosimilars® recaps the top stories for the week of December 2, 2019.
The Center for Biosimilars® recaps the top stories for the week of November 25, 2019.
Biocon announced today that its supplemental Biologics License Application (sBLA) for its biosimilar pegfilgrastim, Fulphila, filed with partner Mylan, has been approved by the FDA.
Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis. The product is the first subcutaneous infliximab option to be approved in any regulatory territory.
The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
In an interview with The Center for Biosimilars®, Sandoz’s Sheila Frame, MBA, vice president of marketing, market access, and patient services, and William Yoon, PharmD, MBA, head of external engagement and medical advocacy, reflected on the past decade of experience with the biosimilar pathway and gave a look at the future of Sandoz’s biosimilar efforts.

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