Regulatory

Senator Warren Introduces Legislation to Create Government Generic Drug Maker

December 19th 2018

By Samantha DiGrande

Senator Elizabeth Warren, D-Massachusetts, has introduced a bill in the Senate that would create an Office of Drug Manufacturing within HHS. Simultaneously, Representative Jan Schakowsky, D-Illinois, introduced an identical bill in the House of Representatives.

With the Future of the ACA in Question, Are US Biosimilars at Risk?

December 19th 2018

By Kelly Davio

While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.

Mylan and Biocon's Trastuzumab Biosimilar Gains European Marketing Authorization

December 19th 2018

By The Center for Biosimilars Staff

Mylan and Biocon have received final approval from the European Commission to market their trastuzumab biosimilar, Ogivri, referencing Herceptin.

Cigna and Express Scripts Merger Earns New York, California Regulatory Approval

December 18th 2018

By Samantha DiGrande

Last week, Insurer Cigna and pharmacy benefit manager (PBM) Express Scripts overcame 2 hurdles to completing their $67 billion merger as New York and California insurance regulators signed off on the deal.

Amgen Submits BLA for Proposed Infliximab Biosimilar

December 18th 2018

By The Center for Biosimilars Staff

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

Pfizer Gains Positive CHMP Opinion for Bevacizumab Biosimilar, Withdraws "Skinny Label" Adalimumab Application

December 17th 2018

By Kelly Davio

On Friday, Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of its proposed bevacizumab biosimilar, PF-06439535, to be marketed under the trade name Zirabev.

FDA Approves Celltrion and Teva's Trastuzumab Biosimilar, Herzuma

December 15th 2018

By Kelly Davio

The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer.

The Top 5 Biosimilars Articles for the Week of December 10

December 14th 2018

The Center for Biosimilars® recaps the top news for the week of December 10, 2018.

FDA Outlines New Plans for Biosimilars in 4 Guidance Documents and Proposed Rule

December 12th 2018

By Kelly Davio

On Tuesday, the FDA took significant steps toward a long-awaited transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars.

United States Still Lags Behind Other Nations in Adopting Biosimilar Filgrastim

December 11th 2018

By Kelly Davio

Since the advent of biosimilar filgrastim, patient access to the prophylaxis of chemotherapy-induced febrile neutropenia has improved in many regulatory territories, yet concerns remain about whether the United States is keeping pace with the rest of the world in biosimilar uptake and associated patient access.