Accord BioPharma Announces FDA Approval of 420mg Strength of HERCESSI™

Accord BioPharma Announces FDA Approval of 420mg Strength of HERCESSI™

By, Admin 20 September 2024

Accord BioPharma Announces FDA Approval of 420mg Strength of HERCESSI™ for HER2-Positive Cancers

Overview

Accord BioPharma has received approval from the U.S. Food and Drug Administration (FDA) for a 420mg strength of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab).

About HERCESSI

  • HERCESSI is designed for the adjuvant treatment of HER2-overexpressing breast cancer, as well as metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. 
  • HER2 cancers are generally aggressive, but they tend to respond positively to targeted treatments. 
  • HERCESSI operates by binding to and deactivating the HER2 receptor, effectively slowing down the replication of cancer cells.

This treatment is intended for HER2-overexpressing breast cancer and gastric or gastroesophageal junction adenocarcinoma. 

The Approval

  • The approval follows an earlier FDA clearance for a 150mg strength of HERCESSI earlier in 2024, and the company plans to launch the biosimilar in the U.S. in early 2025.
  • The FDA granted approval based on a comprehensive set of analytical, preclinical, and clinical studies. 
  • These included two Phase 1 pharmacokinetic studies in healthy volunteers and a Phase 3 study in patients with HER2-overexpressing metastatic breast cancer. 

The results confirmed that HERCESSI is comparable to its reference product, Herceptin, in terms of efficacy, safety, and quality.

Accord BioPharma has stated that the safety profile of HERCESSI aligns with that of Herceptin, and there are no clinically significant differences between the two. 

The company aims to expand the availability of affordable treatment options through its biosimilar portfolio, which will also include future biosimilar versions of pegfilgrastim, filgrastim, and ustekinumab, with several launches planned over the next five years.

HERCESSI 1st Approval

  • Originally developed by Accord’s partner Shanghai Henlius Biotech, Inc., HERCESSI was first approved in April 2024 at a 150mg dosage. 
  • The new 420mg strength will further support Accord BioPharma's efforts to provide cost-effective treatments for cancer patients in the U.S. market.

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