Regulatory

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The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins.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.
The Center for Biosimilars® recaps the top stories for the week of November 18, 2019.
President Trump’s choice to lead the FDA faced some questions, but not many, about drug pricing, according to various press reports about the Senate committee hearing Thursday regarding the nomination of Stephen Hahn, MD, FASTRO, the chief medical officer of MD Anderson Cancer Center.
Perhaps not surprisingly, officials from generic drug companies, reference product companies, the FDA, and the Federal Trade Commission (FTC) have different opinions about the usefulness of various actions the federal government has taken to prevent abuses of risk evaluation and mitigation strategies (REMS), according to a recently released Government Accounting Office (GAO) report.

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