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news.Shanghai Henlius Biotech (Henlius) and Organon have announced the US Food and Drug Administration (FDA) acceptance of the biologic license application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).
The BLA filing is supported by data from a series of head-to-head studies for HLX14, which include comparative quality analytical studies and two clinical trials. Credit: Louis Reed on Unsplash.
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Denosumab has received approval in several countries and regions under different brand names for multiple indications, including osteoporosis treatment in postmenopausal women at high risk of fractures, among others.
In 2022, Henlius signed a licensing and supply agreement with Organon, granting the latter with exclusive commercialisation rights for two biosimilar candidates, including HLX14.
This agreement applies to markets such as the US, the European Union (EU), and Canada, with the exception of China.
The BLA filing is supported by data from a series of head-to-head studies for HLX14, which include comparative quality analytical studies and two clinical trials.
The first was a two-part Phase 1 study involving healthy adult male participants in China. An open-label, randomised, parallel-controlled, single-dose, two arm pilot study, the primary aim of Part 1 was to compare the pharmacokinetic (PK) parameters of HLX14 and EU-sourced PROLIA following subcutaneous injection, thereby providing basis for the design of Part 2 study.
Part 2 was a double-blind, randomised, parallel-controlled, single-dose, four arm study, designed primarily to compare the pharmacokinetic similarity of HLX14 with PROLIA sourced from the US, EU, and China after subcutaneous injection.
The second study was a randomised, double-blind, international multicentre, parallel-controlled Phase 3 trial that assessed the efficacy, safety, tolerability, and immunogenicity of HLX14 compared to EU-sourced reference PROLIA in postmenopausal women suffering with osteoporosis at high risk of fractures.
A global biopharmaceutical company, Henlius specialises in oncology, autoimmune diseases, and ophthalmic disorders.
According to the company, to date, six products have been launched in China, three have received marketing approval in international markets, 24 indications have been approved worldwide, and four marketing applications are currently under review in China, the US, and the EU.
Henlius has a global innovation centre and commercial manufacturing facilities in Shanghai, certified as per GMP standards in China, the EU, and the US.
New Jersey-based Organon is a global healthcare company aiming to help improve the health of women and has about 10,000 employees.
