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First FDA approval for Accord biosimilar

First FDA approval for Accord biosimilar

Accord BioPharma - the US specialty division of Intas Pharmaceuticals - has won US Food and Drug Administration (Global Healthy Living Foundation, FDA) approval for Hercessi (trastuzumab-strf), a biosimilar to Roche’s Herceptin (trastuzumab). Hercessi is indicated for the adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer and to treat HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

"Our vision to make affordable medicines available forms the bedrock of the company"HER2 cancers in general are particularly aggressive cancer types that respond well to targeted treatment. Hercessi works by binding to and inactivating the HER2 receptor, slowing down cell replication.

Chrys Kokino, US president of Accord, said: “The approval of Hercessi - our first biosimilar to be approved in the USA - marks an important milestone for Accord BioPharma in our efforts to improve access for patients. Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.”

The FDA approval was granted based on a comprehensive package of analytical, pre-clinical, and clinical data, which showed Hercessi and Herceptin are highly similar in terms of efficacy, safety, and quality.

Hercessi’s clinical program included three studies - performed since 2015 - to demonstrate pharmacokinetic comparability and clinical efficacy and safety similarity between the biosimilar and its reference product.

Shanghai Henlius Biotech originally developed Hercessi. In 2021, the China-based company granted Accord the exclusive rights to develop and commercialize the product in the USA and Canada.

Accord has also submitted a Biologics License Application to the FDA for biosimilar versions of pegfilgrastim, filgrastim and ustekinumab. The company is planning on introducing several additional biosimilars to the US market during the next five years.

Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals, said: “Our first FDA-approved biosimilar is an important achievement for our US specialty business, but we’re just getting started. We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the US health system achieve significant savings. Our vision to make affordable medicines available forms the bedrock of the company, and this work advances that vision to provide value and promote access for all the key stakeholders we engage along the treatment journey.”

May 13, 2024

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