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Osteoporosis Treatment Advancements: Henlius and Organon Achieve EMA Validation for HLX14 Biosimilar

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Henlius and Organon have achieved a significant milestone as the European Medicines Agency (EMA) validated the Marketing Authorization Applications (MAAs) for osteoporosis treatment HLX14, a biosimilar candidate to Prolia and Xgeva (denosumab). This development could potentially expand treatment options for osteoporosis, especially for postmenopausal women at high risk for fractures.

In 2019, approximately 32 million Europeans aged 50 or older were afflicted with osteoporosis, with women constituting 25.5 million of these cases. Denosumab has already secured approval in numerous countries for treating osteoporosis among postmenopausal women at high fracture risk. The validation of HLX14’s MAAs follows a comprehensive Phase III clinical trial. This international, randomized, double-blind, parallel-controlled multicentre study assessed HLX14’s efficacy, safety, tolerability, and immunogenicity against the EU-sourced reference denosumab (Prolia).

Henlius and Organon Partnership Expands Access to Osteoporosis Biosimilars in Key Markets

In 2022, Henlius and Organon entered into a licensing and supply agreement, granting Organon exclusive rights to commercialize two biosimilar candidates, including HLX14, in key markets such as the European Union, the US, and Canada, excluding China. Organon, a global healthcare company focused on improving women’s health, is also expanding its biosimilar business. The company is headquartered in Jersey City, New Jersey, and employs around 10,000 people. Meanwhile, Henlius, headquartered in Shanghai, continues to make strides in biopharmaceuticals with a focus on oncology, autoimmune diseases, and ophthalmic diseases.

HLX14 aims to offer a cost-effective alternative to Prolia and Xgeva for postmenopausal women at high risk for fractures. The licensing agreement between Henlius and Organon could significantly impact the availability of denosumab biosimilars in major markets. The validation of HLX14 by the EMA adds credibility and paves the way for future approvals in other regions. Organon’s extensive portfolio and Henlius’ innovative pipeline make this partnership promising for future healthcare advancements.


A Milestone in Osteoporosis Treatment and Biopharmaceutical Innovation

The validation of HLX14’s MAAs by the EMA marks a significant step forward in expanding treatment options for osteoporosis. This biosimilar could provide a cost-effective alternative to existing therapies, benefiting millions of postmenopausal women at high risk for fractures. The collaboration between Henlius and Organon exemplifies how strategic partnerships can drive innovation and accessibility in the biopharmaceutical industry.

With both companies leveraging their strengths—Organon’s vast portfolio in women’s health and Henlius’ robust product pipeline—there’s potential for substantial advancements in treating various conditions. This development not only underscores the increasing importance of biosimilars in healthcare but also highlights the ongoing efforts to make effective treatments more accessible to patients globally.


Resource: Shanghai Henlius Biotech, May 24, 2024

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