April 23, 2020

The Center for Biosimilars Features Q&A with Ha Kung Wong on Regulatory Actions to Promote Biosimilars

2 min

On April 23, 2020, Ha Kung Wong was featured in The Center for Biosimilars Q&A regarding recent regulatory actions to promote biosimilars. The following is an excerpt:

Will manufacturers be motivated to bring products to market under the newly established biologics approval pathway under the Biologics Price Competition and Innovation Act?

There’s an important distinction to make. Many biologics that are subject to biosimilars today are older products and their regulatory exclusivity no longer applies. But if it’s a newer product, biosimilar manufacturers are looking at a horizon 12 years away for bringing their product to market based on regulatory exclusivity, so they might have less incentive to develop a biosimilar, even if it’s the same amount of work as making a small molecule generic. That’s 1 reason why we see so many companies making generic medications. In the generic industry, pursuing multiple potential generic products may be beneficial, even if you only succeed in bringing 1 to the market. It’s potentially worthwhile from a return on investment analysis, because you have the potential for 180 days of marketing exclusivity and have automatic substitutability at the pharmacy for the reference product. On top of that, the generic small molecule process is likely less resource intensive than developing a biosimilar.

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