#Shanghai #Europe #Henlius #Organon #POHERDY

Introduction

In a significant milestone for cancer treatment accessibility, the European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab) 420 mg/14 mL injection. Developed through a collaboration between Shanghai Henlius Biotech, Inc. and Organon, POHERDY is recognized as the first and only licensed biosimilar to PERJETA in Europe. This approval marks a critical step toward enhancing options available for patients battling HER2-positive breast cancer, a condition that is alarmingly prevalent among women in the European Union.

Significance of the Approval

With HER2-positive breast cancer being the most commonly diagnosed female cancer in the EU, the EC's endorsement of POHERDY is timely. Joe Azzinaro, Organon's Vice President and Global Commercial Lead for Biosimilars, emphasized the company’s dedication to improving healthcare systems through quality medicinal access, particularly in women's health sectors. As the inaugural biosimilar for pertuzumab, POHERDY promises to broaden treatment options and offer a sustainable healthcare solution amid rising treatment costs.

Overview of POHERDY's Indications

POHERDY is approved for use in various combinations:

1. Combination with trastuzumab and docetaxel for adults suffering from HER2-positive metastatic or locally recurring unresectable breast cancer who have not undergone any previous anti-HER2 therapies.
2. Combination with trastuzumab and chemotherapy for neoadjuvant treatment in patients with locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence.
3. Adjuvant treatment for adults with early breast cancer of the same HER2-positive nature, specifically those at high risk of recurrence.

The approval process involved a rigorous evaluation of significant clinical data confirming that POHERDY closely mirrors its reference product in quality and efficacy, effectively expanding therapeutic options.

Background of Henlius and Organon

Founded in 2010, Shanghai Henlius Biotech is a prominent innovator in biologic therapies and has established an extensive biopharmaceutical operation with nearly 4,000 employees across various regions including China, the U.S., and Japan. Henlius is strategically transitioning into its second phase of globalization, focusing on the development of next-generation biologics and maintaining a robust biosimilar portfolio.

Organon, headquartered in Jersey City, is dedicated to addressing health concerns that disproportionately affect women. By prioritizing women's health, Organon champions not only affordability and accessibility in treatments, but also ensures the integrated delivery of impactful medicines across numerous global markets.

The Future of Treatment Access

The collaboration between Henlius and Organon signifies a pivotal turn in biopharmaceutical strategies for cancer treatment. The successful launch of POHERDY is anticipated to redefine healthcare accessibility, particularly for patients navigating the complexities of HER2-positive breast cancer therapies. Moving forward, both companies will strive to harness their combined innovations towards advancing patient care, while addressing pressing medical needs worldwide.

Conclusion

The approval of POHERDY represents a transformative development in the fight against breast cancer, fostering improved options for patients while underscoring the importance of affordable healthcare solutions. As the European market anticipates broader availability of biosimilars, this initiative sets a foundation for future innovations, promoting both quality of life and treatment access for those affected by cancer.