Update on Chinese and Indian Biotech In the Spotlight

As we reported in our last newsletter (here), ex-US CDMOs and CROs (especially those in China) have been the subject of US political and growing biopharma industry scrutiny.   On June 18, 2024, FDA publicly announced that Sponsors who used Synapse Labs Pvt. Ltd. (a CRO in India) to conduct their bioequivalence or bioavailability studies would need to repeat those studies to support their INDs, NDAs, and ANDAs.  FDA cited significant concerns about the validity and reliability of the data provided by Synapse.  

In addition, for FDA-approved generics products that were supported by data from Synapse, FDA is changing the therapeutic equivalence ratings to “BX” to signify that the FDA deems the data to be insufficient to support therapeutic equivalence (substitutability).  Interestingly, in their letter to Sponsors (here), FDA states that, “A drug with a “BX” rating is still approved and can be prescribed, but is not recommended as automatically substitutable at the pharmacy (or by a pharmacist) for the brand-name drug.”

We previously reported and still stand by our recommendation that FDA will accept data from ex-US organizations as long as what is provided complies with global and local (FDA) regulations and guidances.  We continue to urge Sponsors to oversee ex-US and all third party operations to ensure that your partners are providing the highest quality data to support your regulatory activities.