Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Paxlovid, the company’s small-molecule Covid-19 oral therapy, was shown to reduce Covid-19 infections by 32% in adults and is forecast to be the top-selling drug by total sales, generating $81bn between 2021 and 2028. Bristol Myers Squibb (BMS) documented a 9.1% AbbVie reported a 22.7%

Vaccines 108

Vaccines Drug Pricing Biosimilars Documentation 108

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

FDA Law Blog: Biosimilars

JANUARY 2, 2025

Recognizing that the final rule redefining the term healthy is a significant change from FDAs previous approach (in effect for thirty years), FDA plans to issue guidance documents intended to help industry understand the rule and how to work with FGEs. The compliance date is February 25, 2028.

Labelling 52

Labelling Documentation 52