Biosimilar Regulation Headaches From Morocco To Pakistan

 
• By Ian Schofield
  
Generate a summary of this article
Listen to this article
Beta

Delegates at the recent pre-ICDRA conference heard about the issues dogging the regulation of biosimilar medicines in the Eastern Mediterranean Region, including unfamiliarity with the comparability exercise and a lack of expertise and resources in this area. The question of a "global comparator product" was also raised.

Six oatmeal cookies in two rows. Classic studio flat lay photo on white background with authentic soft shadows. Full frame image with detailed texture of bakery product.
Regional differences cause problems in the regulation of biosimilar medicines

The concept of biosimilar medicines is by now very well established in highly regulated areas like the EU, the US and Australia, which have had clear legislation and regulatory guidance in place for some years. But the situation in some world regions leaves a lot to be desired, with many countries still lacking clearly defined regulations and guidance on biosimilar evaluation and approval.

A case in point is the Eastern Mediterranean region (EMR), where numerous regulators are facing obstacles on a number of...

Generics Bulletin Podcast

Stay ahead of every shift in generics and biosimilars.

Generics Bulletin brings you the latest updates that matter for the off-patent industry.

SpotifyApple PodcastsWebsite

More from Biosimilars

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C7

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C6

 
• By Reed Miller

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

US Biosimilars

An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

Top 10 Drugs Q1 2026: New Sheriff In Town As Mounjaro Unseats Keytruda - Clone - Clone

Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains

More from Products

For Generics, A Victory Lap – And A Warning – On Drug Shortages

Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.

GB-Free-Company-The Secret to Walking More: It’s Not Counting Steps

We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.

Biocon And Teva Sign Up To Biosimilars Forum

Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.