Regulatory

FDA, FTC Pledge Close Cooperation to Create Biosimilar Competition

February 4th 2020

By Allison Inserro

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.

European Medicines Agency Authorizes Marketing of Pfizer's Ruxience

January 31st 2020

By Gianna Melillo

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.

FDA Releases Framework for Assessing Gene Therapies in Anticipation of Future Filings

January 29th 2020

By The Center for Biosimilars Staff

The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.

Faster Drug Approvals, Weaker Data? Study Raises Concerns About FDA Process

January 14th 2020

By Deana Ferreri, PhD

An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.

FDA Touts Biosimilar Approvals in Annual CDER Report

January 8th 2020

By The Center for Biosimilars Staff

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

Spectrum Says Its Novel G-CSF Drug Will Be Reviewed by FDA

January 4th 2020

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

Gilead Submits JAK Inhibitor, Filgotinib, Under Priority Review for Rheumatoid Arthritis

January 2nd 2020

By The Center for Biosimilars Staff

Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).

US Biosimilar Regulatory Roundup: 2019

December 31st 2019

By Kelly Davio

When it comes to US biosimilars, 2019 was the busiest year yet for regulatory activity, with a bevy of new approvals and the publication of long-awaited guidance documents.

"Not So Different": The Year in US Regulatory Activity for Biosimilars

December 29th 2019

When it comes to US biosimilars, 2019 was a busy year for regulatory activity. This week on the podcast, we're rounding up the key developments of the year.

The Top 5 Biosimilars Articles for the Year 2019

December 27th 2019

The Center for Biosimilars® recaps the top stories for the year 2019.