Biosimilar Bytes

An FDA Application Filed for a New Trastuzumab Biosimilar

Accord BioPharma and its manufacturing partner Shanghai Henlius Biotech announced that the US Food and Drug Administration (FDA) accepted its 351(k) application for HLX02, a trastuzumab biosimilar candidate. The company is seeking similar HER2-overexpressing tumor indications as its competitors. If approved, it would be Accord’s first biosimilar approval in the US.

“We’re thrilled to announce this regulatory milestone as we work to provide patients increased options and access for treatment of serious conditions in oncology, immunology, and critical care,” said Chrys Kokino, President of US BioPharma at Accord BioPharma. “Biosimilars are key to making healthcare more affordable and accessible. We’re working to develop the deepest portfolio of biosimilars to enhance the patient experience and improve the cost of care across the continuum.” 

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, hopes to join a very crowded market, with five approved trastuzumab biosimilars and three other companies working towards commercialization or awaiting FDA decisions. HLX02 is already approved for use by the European Medicines Agency and by the China National Medical Products Administration. The development of HLX02 represents the first result of a broader commercialization and marketing agreement Accord signed with Henlius Biotech for additional investigational biosimilars.

New Demonstration Project Would Encourage Biosimilars Use Through Shared Savings

Written by US Representative Richard Hudson (R-NC), the Increasing Access to Biosimilars Act of 2023 was introduced in Congress in March. H.R. 1352 would set up a 3-year Medicare demonstration project that seeks to improve access to part B biosimilars by allowing providers to share in savings attained with use of the products.

The text of the Act states, “in addition to the payment that would otherwise be made…for a biosimilar biological product furnished or dispensed by a participating provider to a Medicare beneficiary, there shall be made an additional payment, in an amount determined by the [HHS] Secretary, that is based on the difference, if any (or portion of such difference), between the costs to the provider in furnishing the biosimilar biological product and the costs to the provider if the provider had furnished the reference biological product.”

No cosponsors have signed on to the Act yet, and the legislative proposal has been referred to the Houses committees on Energy and Commerce, and Ways and Means.

Biosimilar utilization has been shown to save Medicare significant dollars and lower providers’ financial risk when participating in shared-savings models, like the Oncology Care Model (a demonstration project that ended in 2022). This new proposal may be an attempt to continue that momentum.  

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