FDA Law Blog: Biosimilars

AUGUST 29, 2024

Shumsky — As readers of this blog know ( see, e.g. , here ), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. The latest iteration of the Preserve Access to Affordable Generics and Biosimilars Act making its way through Congress is Senator Amy Klobuchar’s (D-MN) S.

Biosimilars 59

Biosimilars Licensing Licensing Production 59

Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! WHAT’S GOING ON Twice a year, I research and write two comprehensive, fact-based, and nonpartisan reports on drug channel economics.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Biosimilars 40

The Pharma Data

DECEMBER 21, 2020

executive vice president of Research and Development at Amgen. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Respir Med 2006 : 100 (7): 1139-51.

Trials 40

Trials Production Clinical Trials Government 40

Agency IQ

JULY 28, 2023

A big legislative question about PAHPA Reauthorization : The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation.

FDA 40

FDA Science Biosimilars Regulations 40