Lost in all the initial misreporting of the Supreme Court decision and even in the correct subsequent reporting was the positive impact the ruling had for Pharma and Biotech companies pursuing biosimilars. There had been fear that if the Court had struck down mandatory purchase of insurance provision portions of the law that the whole house would come tumbling down. And with the fall of the Patient Protection and Affordable Care Act (PPACA) law, the the Biologics Price Competition and Innovation Act (BPCIA) would go too!
Fortunately for the biotech industry, that did not happen. We still have a pathway in place to get to biosimilars filed and hopefully someday approved in the US. Biologic drugs totaled $112.93 billion in worldwide sales in 2011, which constituted a $5 billion, or 4.6 percent, increase over 2010 sales. Europe, in particular, has had a biosimilar pathway in place for nine years (since 2003), and has approved at least fourteen biosimilar products so far. The US needs to get it in gear.
The European biosimilars market generated is expected to reach almost $4 billion by 2017. Despite these profit incentives, and despite the framework being in force for over two years already, no biosimilars have been approved in the U.S., and most indications are that none are close (as of February, the FDA had yet to receive its first ABLA application). BIO has been advocating that the new biosims that will compete with branded products should be put through a rigorous clinical trial program, avoiding the onslaught of cheap copycats that has blighted traditional small molecule treatments
The Supreme Court decision erases any hesitation biosimilar producers may have had in using the BPCIA due to the uncertainty of its survival. Biosimilar producers can now move forward full steam with their biosimilar products without fear of legislative overhaul and potential disruption of their FDA approval progress. Pioneer biosimilar producers such as Sandoz and Hospira are already in Phase III human testing, and they have relied on the BPCIA to provide some clarity as to how biosimilars will be regulated in the U.S. Some of the biggest companies, like Merck, Amgen and BiogenIdec, have also set up biosimilar initiatives too.
The survival of the BPCIA is welcome news for biologics patient consumers as well, who hope to see lower prices in the near future on these important and typically costly drugs. See Patent Docs blog, In the Pipeline, and Fierce Biotech.
Posted by Bruce Lehr Jun 30th 2012.