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New FDA policies will lead to approvals of interchangeable insulin products that can be automatically substituted for branded insulin, FDA Commissioner Scott Gottlieb said Tuesday.
Gottlieb made the prediction in a statement about new guidance documents that outline how FDA will implement a law requiring that it stop regulating certain biologics, such as insulin and human growth hormone, as drugs. Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), biologics that have been approved under NDAs will be deemed on March 23, 2020, to be approved under BLAs.
The quirk in U.S. law that has regulated insulin under NDAs has limited competition because it has been difficult to satisfy FDA’s requirements for a generic drug. The first biosimilar insulin was approved by EMA in 2014.
“Given our long experience regulating insulin products, and high interest among sponsors who are proposing to develop interchangeable insulins, we’re confident that interchangeable insulins – insulins that will be available for automatic substitution at the pharmacy level – will be attainable after the transition to deemed BLAs in March 2020,” Gottlieb said.
Gottlieb called the transition from NDA to BLA a “watershed moment for insulin products,” one that will create competition that will dramatically reduce prices and increase access.
The introduction of interchangeable insulins, Gottlieb said, will disrupt a pricing system that has led to an upward spiral of list prices for insulin that are linked to ever-higher rebates that the three manufacturers who dominate the U.S. market pay to PBMs to jockey for preferred status on formularies. Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO), Eli Lilly and Co. (NYSE:LLY) and Sanofi (NYSE:SNY) sell almost all insulin used in the U.S.
FDA is implementing the transition of NDAs for biologic into BLAs in ways that are intended to promote competition, Gottlieb said.
For example, drugs that transition to BLAs will not be eligible for the 12 years of market exclusivity that is available to newly licensed biologics.
FDA also announced that supplements to approved NDAs of biologics that are pending on March 23, 2020, will be administratively converted into BLA supplements.
The agency has approved at least two insulin products under section 505(b)(2), a regulation that allows follow-on drugs to reference safety and efficacy data of approved drugs. The agency granted 505(b)(2) approval to Sanofi’s Admelog Humalog insulin lispro in December 2017 and to Lilly’s Basaglar insulin glargine in December 2015. In July 2017, FDA granted tentative 505(b)(2) approval to Merck & Co. Inc. (NYSE:MRK) for Lusduna insulin glargine pending the outcome of a patent infringement suit brought by Sanofi, but Merck terminated its commercialization deal with Samsung Bioepis Co. Ltd. for Lusduna in October of this year.
Unlike biosimilars that are designated as interchangeable, 505(b)(2) drugs cannot be automatically substituted by pharmacists.
FDA issued a complete response letter in June to a 505(b)(2) application from Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) for a follow-on version of Lantus insulin glargine. At the time, Mylan said it expected the CRL as it agreed to provide FDA additional data to support a manufacturing site change. The product has been approved as a biosimilar in Europe and Australia. Mylan has told BioCentury it plans to launch the product in the U.S. in 2020.