2022, Biosimilars, Pharmacokinetics and Small Molecule

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

2022

Biosimilars

Pharmacokinetics

Small Molecule

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. In the US, new small molecule drugs are developed under the requirements of Sections 505(b)(1) and 505(b)(2) of the FFDCA. 8] US Food and Drug Administration (FDA).

FDA

FDA Animal Testing Pharmacokinetics Small Molecule

Drug Discovery Digest

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The FDA Modernization Act 2.0: The End of IND-Enabling Toxicology Studies?

Stay Connected