Accord BioPharma Announces FDA Approval for HERCESSI™
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, has achieved a major milestone in cancer treatment with the FDA's approval of a new 420mg strength of HERCESSI™ (trastuzumab-strf). This biosimilar to Herceptin (trastuzumab) targets different types of HER2-overexpressing cancers, such as breast and gastric cancers. With this approval, alongside the prior approval of a 150mg strength, the company is set to introduce its first biosimilar to the U.S. market in early 2025.
Commitment to Innovative Cancer Treatments
Chrys Kokino, U.S. president of Accord BioPharma, underscored the company's commitment to ensuring essential medications are within reach for patients. He pointed out that cancer treatments often come with a heavy financial burden, and Accord seeks to ease that strain by offering cost-effective biosimilars like HERCESSI. Their mission resonates deeply with the realities of cancer patients, reflecting a strong commitment to improving access to these vital treatments.
Indications and Benefits of HERCESSI
HERCESSI is indicated for adult patients undergoing adjuvant treatment for HER2-overexpressing breast cancer, as well as for those dealing with metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. HER2 cancers are usually more aggressive but tend to respond favorably to targeted therapies. HERCESSI works by binding to the HER2 receptor, effectively disrupting cell growth.
Robust Clinical Data Supporting Approval
The FDA's approval of HERCESSI was based on extensive preclinical and clinical studies. Three dedicated studies confirmed the comparable efficacy, safety, and quality of HERCESSI and its reference product, Herceptin. Additionally, the data highlighted HERCESSI's strong performance in two Phase 1 pharmacokinetic studies with healthy volunteers, along with a meaningful Phase 3 comparative study involving patients with HER2-overexpressing metastatic breast cancer.
Continuing the Legacy of Innovation
Accord BioPharma's work in the biosimilar sector showcases a longstanding dedication to innovation. Binish Chudgar, vice chairman and managing director of Intas Pharmaceuticals, noted that the company’s extensive experience in introducing biosimilars to regulated markets, particularly in the EU, has well-prepared them for their U.S. launch. The approval of both the 420mg and 150mg strengths of HERCESSI marks a critical step in Accord's expansion of its biosimilar portfolio in the U.S., with the goal of providing cost-effective treatments for patients battling breast and gastric cancer.
Collaboration with Henlius Biotech
The development of HERCESSI was made possible through a partnership with Shanghai Henlius Biotech. This collaboration aims to bring together innovative approaches to create high-quality treatment options for patients. It highlights the shared commitment to developing affordable and effective therapeutics for individuals facing cancer.
Future Directions for Accord BioPharma
As they look to the future, Accord BioPharma has ambitious plans that include submitting Biologics License Applications for additional biosimilars, like pegfilgrastim, filgrastim, and ustekinumab. Over the next five years, they are committed to expanding their offerings, ultimately enhancing the therapeutic landscape for patients who require diverse cancer treatments.
Frequently Asked Questions
What is HERCESSI?
HERCESSI is a biosimilar to Herceptin, approved for treating HER2-overexpressing breast and gastric cancers.
Who developed HERCESSI?
HERCESSI was developed by Accord BioPharma in collaboration with Shanghai Henlius Biotech.
What strengths of HERCESSI are FDA approved?
The FDA has approved HERCESSI in 150mg and 420mg strengths for commercial use.
When will HERCESSI be available in the U.S.?
HERCESSI is expected to be commercially launched in the U.S. in early 2025.
What are the primary uses of HERCESSI?
HERCESSI is indicated for the treatment of various forms of HER2-overexpressing cancers including breast and gastric cancers.
