On June 26, 2019, Ha Kung Wong was featured in a Biosimilar Development Q&A on how the biosimilar market is currently unfolding in the U.S., some of the lessons that can still be learned from other countries, as well as what have been the biggest innovations to occur in the biosimilars space thus far. The following is an excerpt:
What have we learned from biosimilar experience in Europe, and do you think that this has implications for some of the hurdles to biosimilars in the U.S.?
Governmental regulation can have a big impact on biosimilar usage. Drug usage is more regulated in Europe, and policies to increase biosimilar usage such as tenders (competitive bidding process that rewards the party/parties with the best prices), prescribing quotas and targets (goals for prescribing biosimilars in a certain percentage of patients), and national guidelines that recommend using biosimilars in naïve patients have helped to increase usage in Europe.
There have been significant discussions in the U.S. about the need for improved pharmaceutical regulation, but no significant legislation has yet been passed to increase biosimilar usage. Unfortunately, while a step in the right direction, many of the pending bills don't really take significant steps to increase usage.