Will Biosimilars Deliver on Lower Price Promises?
As the debate over affordable healthcare continues to rage in the US, it is time to consider whether the introduction of biosimilars is having a meaningful impact on the cost of biologic medicines. One of the major arguments for the development of biosimilars was the prospect of making these medicines more affordable and accessible to patients worldwide. Back in 2012, we commented on the first regulatory application for a biosimilar monoclonal antibody (mAb) submitted to the EMA. At the time, there was much debate over the potential cost savings of biosimilars versus the original innovator product. It was generally anticipated that biosimilars would be priced at a 30-40% discount relative to the innovator product, but at least one company (Samsung) predicted prices of up to 50% off the innovator drug price. Unfortunately, the goal of introducing a truly affordable biosimilar at these steeply discounted prices continues to elude us.
Earlier this year, Patti participated in a panel discussion at the DIA CMC Workshop examining the pace of biosimilar development and the evolution of regulations overseeing their development and approval. Unfortunately, while biosimilar approvals continue to rise (there are currently 29 biosimilars approved in Europe and five in the US), the lower prices everyone has hoped for have been slow to materialize. Back in October 2016, Pfizer launched Inflectra®, its biosimilar infliximab, with a modest discount of only 15 percent compared to the list price of Remicade®.
Some progress in making biosimilars affordable was achieved last month when Merck & Co. and Samsung Bioepis launched Renflexis™, their infliximab biosimilar, at a 35% discount to Remicade’s list price. This still doesn’t come close to Norway and Denmark, where an infliximab biosimilar is available at a discount of more than 60% relative to the innovator product.
Towards this end, we are encouraged by FDA director Scott Gottlieb’s vision of bringing more competition to expensive medicines a priority in helping lower drug costs. Back in 2008, before the BCPI Act was implemented and while he was a Resident Fellow at the American Enterprise Institute for Public Policy Research, Dr. Gottlieb argued that an abbreviated regulatory pathway for biosimilars could produce cost savings and expand access to treatment. More recently he praised the EMA’s “regulatory process that creates genuine savings,” while stating that FDA “still has to make key regulatory decisions” about labeling, interchangeability, and bioequivalence. On the topic of interchangeability, FDA has taken the lead among regulatory authorities, releasing its draft guidance on demonstrating interchangeability in January of this year. These steps towards interchangeability and FDA’s increased pace of biosimilar approvals make us optimistic that biosimilar prices will continue to drop, to the point where the vision of affordable biologics may one day become reality. We welcome your thoughts on this topic as we continue the discussion on-line.