The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 provided a regulatory pathway for biosimilar products in the US. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference (biologic) product. There can be minor differences in the clinically inactive substance such as the buffer or the stabilizer used.
The concept of biosimilars came into existence to curb the rising cost of biologic drugs. Biosimilars are expected to have saved Europe $44 billion by the end of 2020. In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next 5 to 10 years. However, out of 27 approved biosimilars in the U.S. as of 19 June 2020, only 17 have so far been launched.
Biosimilars at present constitute only 2.3% of the U.S. biologics market. Where 90% of global biosimilars sales take place in Europe, 60% of overall biologics sales occur in the U.S. This results in significant healthcare costs in the U.S. In Europe, biosimilars are usually launched soon after approval and immediately after the patent / marketing exclusivity expiry dates of the originator biologics. However, in the U.S. this is often not the case, with launch dates coming years after FDA approval in some cases. According to Juliana Reed, President of the Biosimilars Forum, the only way for the US to change the current situation is to implement measures to support a viable US biosimilars market’.
So what is stopping the biosimilar companies from launching their products when FDA has already approved them?
Well, the reasons for delays in launching biosimilars and the sluggish biosimilars market in the U.S. may include anti-competitive behaviors and other market and regulatory dynamics that currently discourage market uptake of biosimilars. Most importantly, this is usually due to patent challenges and possibly not due to clinical factors. The FDA might have approved the biosimilars based on the data that showed the proposed biosimilar to be highly similar with little or no clinically meaningful differences. However, the reference product manufacturer may be stating that the biosimilar manufacturer may be infringing upon their patents. The biosimilar manufacturer can very well go ahead and launch the product even before the court judgment, which is called an “at-risk” launch. But if the reference product manufacturer wins the case, the court might ask the biosimilar manufacturer to compensate the lost revenue for the period for which the biosimilar was launched which can be very expensive and might be unbearable.
There appears to be no easy, near-term fix for the biosimilar US situation. However, one can anticipate that in the next decade, healthcare systems and Pharma companies will re-evaluate existing and develop new drug pricing models, potentially receiving a significant boost from the accelerated digital transformation in healthcare. As a result, biosimilars might be viewed in a different light by payors and companies, and their market share could indeed increase (as it should) in the US.
#biosimilars #marketaccess #biologics
Sources
http://www.gabionline.net/Reports/Approval-and-launch-dates-for-US-biosimilars
http://www.pmlive.com/pharma_intelligence/Will_biosimilars_ever_catch_on_in_the_US_1322729
https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products
https://www.biosimilardevelopment.com/doc/the-case-for-optimism-in-the-u-s-biosimilar-market-0001