pharmaphorum

FEBRUARY 23, 2022

Adoption of biosimilars in the US has been notoriously slow, but biosimilars manufacturers and outside observers expect this to change rapidly in the coming years. One way in which the pharmaceutical industry and regulators have reacted is by developing or facilitating the development of biosimilars. The short story so far.

Biosimilars 98

Biosimilars Vaccines 98

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). covered insulin product or vaccine). state pharmaceutical assistance programs).

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

pharmaphorum

MAY 17, 2021

Arecor is also working on a portfolio of various hospital specialty drugs and future applications are likely to be to create novel biologicals, biosimilars, therapeutic vaccines and therapeutic peptides.

Diabetes 52

Diabetes Biosimilars Hospitals Vaccines 52

Safe Biologics

APRIL 25, 2023

1] Of cancer medicines launched globally between 2011 and 2019, more than 96% are available to US patients while only 65% are available in other developed nations such as Australia, Japan and the UK. 1] “Europe negotiates a poor vaccine rollout”; Forbes, April 2021 2 IQVIA Analytics, FDA, EMA, PMDA, and TGA data. 5 * [link]

Drug Pricing 130

Drug Pricing Biosimilars Vaccines 130

Safe Biologics

APRIL 25, 2023

1] Of cancer medicines launched globally between 2011 and 2019, more than 96% are available to US patients while only 65% are available in other developed nations such as Australia, Japan and the UK. 1] “Europe negotiates a poor vaccine rollout”; Forbes, April 2021 2 IQVIA Analytics, FDA, EMA, PMDA, and TGA data. 5 * [link]

Drug Pricing 130

Drug Pricing Biosimilars Vaccines 130

European Pharmaceutical Review

DECEMBER 23, 2024

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA. EMA/CHMP/ICH/425213/2011. Internet] Vaccines Europe. September 1999, CPMP/ICH/365/96. Eglovitch JS. EU Official Says ICH Q6B Is Outdated And Needs Revision. Internet] Regulatory Focus. cited 2024August]. Available from: [link] 4. Pharmaceutics.

Biosimilars 52

Biosimilars Vaccines 52

pharmaphorum

FEBRUARY 5, 2021

The FDA has developed in line with the life sciences industry during Woodcock’s time and has kept pace with development of innovations such as cancer cell therapies, biosimilars and digital therapeutics. Hahn had to fight off pressure from the Trump administration to approve Pfizer’s vaccine early.

Vaccines 119

Vaccines Biosimilars Labelling 119