Regulatory Blog

In an era of rapid pharmaceutical innovation, global collaboration is key to expediting patient access to new therapies. To help patients...

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the " Licensing of Biosimilar Products " in...

Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...

On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a...

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (13 December 2023) released an updated guidance on "Guidelines for...

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...

Earlier this Monday (18 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center...

Today (31 July 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

Yesterday (21 June 2023) Switzerland's Swissmedic released an updated guidance on "Authorisation Biosimilar" which specifies the...

Recently (08-November-2022) the Medicines and Healthcare products Regulatory Agency (MHRA) released updated Guidance on the licensing of...

US Food and Drug Administration on 17th September, 2021 finalized additional questions and answers related to biosimilar development and...

What is a Biosimilar Medicine? Biosimilar medicine is a biological medicine that is developed to be highly similar and clinically...