Steps Needed to Speed Biosimilar Market Entry: Study
Four Harvard Medical School researchers say the hope that rising drug prices could be addressed in part by biosimilars has not been realized for a number of reasons. In an online article for the American Society for Clinical Pharmacology and Therapeutics, the researchers say there are steps the federal government and states can take to bolster the biosimilar market in the near-term.
While an abbreviated pathway for biosimilars was approved by Congress in 2010, as of 11/2018, the article says, FDA had approved only 13 products, of which just six were available for patients to use.
“Despite the small number of products that have entered the market and their modest cost-savings to date,” the researchers write, “biosimilars have the potential to play an important role in containing rising U.S. prescription drug prices. To achieve this promise, policymakers must address existing manufacturing, regulatory, and marketing barriers to market entry and uptake, including trade secret protection of critical manufacturing information, pre-approval testing requirements, a lack of interchangeability guidance, patent thickets, rebate traps, and physician and patient skepticism. While some reforms are underway, more can be done to ensure that biologic therapies are available to all patients who need them.”
The authors say that the 6/2018 FDA Biosimilar Action Plan contains some steps that could be helpful, including developing new review tools such as standardized review templates and models correlating pharmacokinetic and pharmacodynamic testing with clinical outcomes, exploring the feasibility of data sharing agreements with regulators in other countries to enable use of non-U.S. licensed products as comparators, and creating a new Office of Therapeutic Biologics and Biosimilars.
They also cite the plan’s call for final or revised draft guidance on demonstrating interchangeability and for continued education of healthcare professionals. Without further details, they say, it’s unclear how effective these steps will be. They also suggest that Congress could pass new legislation that would condition FDA approval of originator biologics on disclosure of manufacturing trade secrets in BLAs upon expiration of the 12-year regulatory exclusivity period.
To address regulatory obstacles to biosimilar entry and uptake, the article says, FDA could coordinate with other international regulators to create uniform pre-approval study requirements with the ultimate goal of a single application dossier that would be sufficient across all jurisdictions.
The authors also include suggestions to address interchangeability, reduce marketing barriers, and mitigate physician and patient skepticism.