Regulatory

Subcutaneous Formulation of Celltrion's Biosimilar Infliximab Authorized by European Commission

November 26th 2019

By Kelly Davio

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.

FDA Releases Draft Guidance on Insulin Biosimilars, Interchangeable Insulins

November 25th 2019

By Kelly Davio

The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins.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.

Sandoz Execs Reflect on a Decade of Experience With the BPCIA, Look to Biosimilars' Future

November 22nd 2019

By Kelly Davio

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 Top 5 Biosimilars Articles for the Week of November 18

November 22nd 2019

The Center for Biosimilars® recaps the top stories for the week of November 18, 2019.

Senate Hearing Focus for FDA Chief Centers Away From Drug Pricing

November 21st 2019

By The Center for Biosimilars Staff

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.

GAO Report: Reference and Generic Sponsors Look Differently at FDA REMS Enforcement

November 20th 2019

By Allison Inserro

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.

Europe Weighs the Merits of Duplicate Marketing Authorizations for Biologics

November 20th 2019

By Kelly Davio

This month, the European Commission’s Pharmaceutical Committee, part of the Health and Food Safety Directorate-General, updated EU member states as to the results of a targeted consultation it undertook in 2018 on a specific type of duplicate marketing authorization applications (MAAs) for originator biologics and their potential impact on biosimilars.

The FDA Will Review Samsung Bioepis' Proposed Bevacizumab Biosimilar, SB8

November 19th 2019

By Kelly Davio

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

Biosimilars Make Progress in the Canadian Market, but Stakeholders See More Work Ahead

November 18th 2019

By Kelly Davio

While much attention over the past few weeks has been on the US biosimilars market, with its recent approvals and product launches, Canada has also been making strides in its own biosimilars experience.

FDA Approves Pfizer's Adalimumab Biosimilar, Abrilada

November 16th 2019

By Kelly Davio

The FDA has approved Pfizer’s adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira.