Regulatory

The Top 5 Biosimilars Articles for the Week of December 3

December 7th 2018

The Center for Biosimilars® recaps the top news for the week of December 3, 2018.

Amgen Filed Nearly 3 Times More Patents on Enbrel in US than EU or Japan, Report Finds

December 7th 2018

By Samantha DiGrande

In the United States, Amgen has 57 patents on Enbrel, whereas in Europe it has 20, and in Japan it has 18.

International Trade Committee Votes in Favor of SPC Amendments

December 6th 2018

By Samantha DiGrande

Last month, the European Parliament’s Health Committee introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers. On December 4, 2018, the committee voted in favor of the amendments.

FTC "Ready to Work Closely" With FDA on Abuse of Citizen Petitions

December 6th 2018

By The Center for Biosimilars Staff

In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs. Now, in a comment letter, the Federal Trade Commission (FTC) has said that it stands ready to work with the FDA on curtailing abusive petitions.

The Biosimilars Forum Joins Calls for FDA Action on Biosimilar Communications

December 3rd 2018

By Kelly Davio

The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA to clarify appropriate sponsor communications about biosimilars.

The Top 5 Biosimilars Articles for the Week of November 26

November 30th 2018

The Center for Biosimilars® recaps the top news for the week of November 26, 2018.

JCR Launches the First Biosimilar Agalsidase Beta

November 29th 2018

By Kelly Davio

JCR Pharmaceuticals announced yesterday that it has launched its biosimilar agalsidase beta product, referencing Fabrazyme, in Japan for the treatment of Fabry disease. JCR developed the drug in partnership with Amicus Therapeutics and GlaxoSmithKline.

FDA Approves Celltrion's Rituximab Biosimilar, Truxima

November 29th 2018

By Kelly Davio

The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs).

Sandoz Gains European Authorization for Pegfilgrastim Biosimilar, Ziextenzo

November 27th 2018

By The Center for Biosimilars Staff

Sandoz announced today that the European Commission has granted a marketing authorization for its pegfilgrastim biosimilar, Ziextenzo, referencing Neulasta.

European Commission Authorizes Pegfilgrastim Biosimilar, Pelmeg

November 26th 2018

By The Center for Biosimilars Staff

The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.