Organon, a global specialist in women’s health and expert in biosimilar commercialization, announced in mid-June 2022 that it had entered into an agreement with Shanghai Henlius Biotech, Inc. As part of this, Organon will license commercialization rights for biosimilar candidates referencing Perjeta (pertuzumab), and Prolia/Xgeva (denosumab) and will have global rights except for in China and its territories.
Pertuzumab is used in the treatment of women that have human epidermal growth factor receptor 2-positive (HER2+) breast cancer and denosumab is used to treat women with osteoporosis. With their experience in biosimilars and women’s health, Organon aims to help more patients gain access to these treatments for breast cancer and osteoporosis, two areas that significantly impact the health of women.
Pertuzumab was first developed by Roche and marketed as Perjeta. It is a monoclonal antibody that inhibits the dimerization of HER2 with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation. Pertuzumab is used in combination with trastuzumab and docetaxel for the treatment of metastatic HER2+ breast cancer; it is also used in the same combination as a neoadjuvant in early HER2+ breast cancer [1].
Denosumab was first developed by Amgen and marketed as Prolia and Xgeva. It is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone [2].
The agreement between Organon, a Merck spinoff and now standalone company [3], and Henlius also includes an option to negotiate an exclusive licence for global commercialization rights for a biosimilar candidate referencing Yervoy (ipilimumab) that can be used to treat women with advanced cervical cancer [4]. The deal includes an upfront payment of US$73 million as well as additional payments upon the achievement of certain development, regulatory and commercial milestones. Henlius will develop the products while Organon will commercialize them.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pertuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-pertuzumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-denosumab
3. GaBI Online - Generics and Biosimilars Initiative. Organon launches as new global women’s health company and appoints leaders in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/pharma-news/organon-launches-as-new-global-women-s-health-company-and-appoints-leaders-in-latin-america
4. GaBI Online - Generics and Biosimilars Initiative. Innovent starts phase II trial for ipilimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jun 24]. Available from: www.gabionline.net/biosimilars/news/innovent-starts-phase-ii-trial-for-ipilimumab-copy-biological
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