Biosimilar Regulation Headaches From Morocco To Pakistan

 
• By Ian Schofield
  
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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.

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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...

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