Thus far, biosimilar uptake has been low in the United States, with market shares for most biosimilars under 10%. Given the cost-saving potential, trying to increase biosimilar uptake has been high on Congress's agenda and there are many bills pending before it dealing with issues from a variety of angles. But will they actually help to bring biosimilars to market more quickly?
While the biosimilar market in the United States has gotten off to a relatively slow start compared with Europe – where biosimilars have been available since 2006 – it has recently gained momentum and will continue to grow in the coming years as more blockbuster biologics lose regulatory exclusivity and patent protection.
As of July 2017 there had been at least 363 inter partes review petitions filed against patents listed in the Food and Drug Administration's Orange Book and 74 filed against patents that have been identified as reading on Purple Book Centre for Drug Evaluation and Research-listed biologic drugs. Of these 437 inter partes reviews, 116 resulted in a final written decision. There are a number of lessons to be learned from these.
There has been some concern regarding the statistics periodically issued by the US Patent Trial and Appeal Board, owing to the fact that the reported numbers overlook multiple inter partes review challenges to the same patents and, potentially, different outcomes in those challenges. While certain drug patents have been challenged in multiple inter partes review petitions, concern as to different outcomes appears to be unfounded.
The US Patent Trial and Appeal Board (PTAB) recently released updated statistics showing the fate of resolved inter partes review proceedings. These statistics show that a total of 4,563 inter partes review petitions were resolved as of March 31 2017, including 1,577 final written decisions. In 81% of these final written decisions, at least some instituted patent claims were found unpatentable. This statistic has contributed to concerns that the PTAB is a patent 'death squad'.