Global Regulatory Harmonization for Biosimilars

The reinvention of the AAM’s Fall conference from The Fall Technical Conference to the GRx + Biosimilars Conference continues to be a success.  This year’s meeting included a very stimulating and informative agenda pertinent to generic drugs and biosimilar products.

On Monday morning, Suzette Kox, MSc, Pharm. Sec’y. Int’l. Generic and Biosimilar Medicines Association (IGBA) spoke on The Importance of Global Regulatory Harmonization for Biosimilars.  IGBA is a member of the International Conference on Harmonisation of Technical Requirements (ICH) Management Committee and plays a lead role in addressing the needs of the generic and biosimilar manufacturers at ICH meetings.

Suzette illustrated the need for greater harmonization in the global regulation of biosimilars by the fact that Europe is the clear leader in approved biosimilars, with 54 approved products compared to the USA which is a distant second-place contender with 24 biosimilars approved.  Japan and Canada are not far behind with 18 and 17 approved biosimilars, respectively.  Furthermore, she highlighted the significant variability in market penetration from country to country for the marketed biosimilars in the EU.

She posits that the benefits of establishing a more global biosimilars development framework would include reduction in regulators workloads through regulatory convergence and international collaboration, and reduction in the need to repeat clinical studies to demonstrate biosimilarity in multiple countries.  Approval of biosimilar products might also be streamlined through the establishment of global comparator products as a harmonization effort as proposed by Christopher Webster and Gillian Woollett <here>.  Currently, the USA and the EU require extensive bridging studies between a foreign-sourced reference product and the reference product approved in their own region, in order to allow clinical data from the foreign-sourced reference product to be used to support a biosimilar marketing application.

Finally, the use of Real-World Evidence could be leveraged to better understand the clinical experience with biosimilar products globally, and possibly to reduce the immunogenicity concerns that hinder the approval of interchangeable biosimilar products in the USA.