Theramex to market Prolia biosimilar in Europe and Australia

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UK-based pharmaceutical company Theramex UK Ltd, which focuses on women’s health, has announced an agreement with India’s Enzene Biosciences Limited for the registration and commercialisation of a Prolia (denosumab) biosimilar in Europe and Australia.


On 10 June 2021, Theramex UK announced signing a license and supply agreement with Enzene Biosciences Limited, which is headquartered in Pune, India, for the registration and commercialisation of a denosumab biosimilar.

Denosumab is a monoclonal antibody treatment for osteoporosis, as well as other causes of bone loss such as metastases to bone and bone-loss caused by certain medications. Denosumab targets receptor activator of nuclear factor kappa-B ligand (RANKL), which controls bone absorption, and is administered by subcutaneous injection once every six months. It is sold under the brand name Prolia by the originator company Amgen.

Under the agreement, Theramex’s biosimilar will be for sale in Europe (including Switzerland and the UK) and Australia. Enzene will exclusively supply the finished product to Theramex for the duration of the agreement.

Robert Stewart, CEO of Theramex, said: ‘The addition of this biosimilar to our existing portfolio continues our strategic determination to improve access and affordability of important treatments to patients. The care and good management of bone health is critical to Theramex. From our recently launched Vitamin D small gel capsule that is easy to take, to our a gastric resistant third-generation bisphosphonate that allows patients to take their medication with or without food, and our cost-efficient teriparatide biosimilar with an easy-to-use pre-filled syringe, we are helping to improve the quality of life for women’.

Theramex produces two teriparatide biosimilars (Livogiva and Qutavina), which are also used in the treatment of osteoporosis [1].

Director of Enzene Himanshu Gadgil added: ‘Enzene is dedicated to the development of affordable treatment options for patients. As such, I am delighted that Enzene and Theramex will be working together to provide women in Europe, the UK, Switzerland, and Australia with access to denosumab, a biosimilar treatment for osteoporosis’.

Korean pharmaceutical company, Huons Lab, has recently announced the development of its own denosumab biosimilar [2], joining Samsung Bioepis, Henlius and JHL Biotech.

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1. GaBI Online - Generics and Biosimilars Initiative. EMA approves bevacizumab and teriparatide biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 25]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. Huons Lab and PanGen Biotech to develop denosumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 25]. Available from:

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Source: Theramex UK

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