Theramex, a leading global speciality pharmaceutical company dedicated to women and their health, has entered into an agreement to register and commercialise denosumab from Enzene Biosciences Limited, Pune, India, for use in Europe, the UK, Switzerland, and Australia.
Denosumab, a biosimilar of the reference medicine Prolia, is an antiresorptive treatment for osteoporosis with sales in these markets of close to €1 billion in 2020.
Enzene will exclusively supply the finished product to Theramex for the duration of the agreement.
Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts.
Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone. Denosumab is administered by a single subcutaneous injection once every six months.
Robert Stewart, Chief Executive Officer at 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.”
Himanshu Gadgil, Whole-Time Director at Enzene said: “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.”