Theramex, a leading global specialty pharmaceutical company committed to promoting women and their health, has signed an agreement with Enzene Biosciences Limited to develop, approve and commercialize a biosimilar of Roche's reference drug RoActemra® (tocilizumab) closed. Tocilizumab is approved in combination with methotrexate (MTX) for the treatment of patients with rheumatoid arthritis. The biosimilar is to be launched in Europe, Great Britain, Switzerland and Australia from 2026.

Theramex's tocilizumab will be available in parenteral ampoules, pre-filled syringes for subcutaneous use, and auto-injector form. The reference product RoActemra® is indicated for the treatment of severely active and progressive rheumatoid arthritis (RA) in adult patients who have not previously been treated with methotrexate, for the treatment of moderate to severe rheumatoid arthritis in adult patients who are inadequate on disease-modifying anti-inflammatory drugs ( DMARD) or TNF blockers, or who did not tolerate them, for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older who have had an inadequate response to previous therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.

Rheumatoid arthritis is a chronic condition that causes pain, swelling, and stiffness in the joints. Usually the hands, feet and wrists are affected by the disease. It takes a relapsing course, which means there may be phases (relapses) in which the symptoms worsen. The relapses are often difficult to predict. However, through treatment it is possible to reduce the number of relapses and minimize or prevent long-term joint damage. Some people with rheumatoid arthritis also experience problems with other parts of the body or more general symptoms such as fatigue and weight loss. 1

“Rheumatoid arthritis affects women more often than men. With the addition of this biosimilar to our existing rheumatology portfolio, we are staying true to our strategy of improving access to and affordability of important drugs for women. We are pleased that our focus now includes rheumatoid arthritis in rheumatology, so we can help more patients with bone disease and joint future, " explained Robert Stewart , CEO of Théramex.

Dr. Himanshu Gadgil , Enzene's Whole Time Director, said: “Enzene’s development of tocilizumab, born of our innovative efforts in making monoclonal antibodies, is another highlight in a number of efforts by our company. We are guided by our mission to provide patients with affordable, improved access to important drugs. Our partnership with Theramex underscores our goal of providing affordable medicines to patients around the world. "

About Theramex

Theramex is a leading global specialty pharmaceutical company committed to protecting women and their health. With a broad portfolio of innovative and established brands in the fields of contraception, fertility, menopause and osteoporosis, Theramex supports women in every phase of life. We strive to listen to women, understand them and meet their needs, and provide them with health solutions that help improve their quality of life. Our vision is to be a lifelong partner for women and the health care professionals who treat them by providing patient-centered, effective solutions that care and support women at every stage of life.

About Enzene Biosciences Ltd.

Enzene is an innovation-focused biotechnology company and a subsidiary of Alkem Laboratories Ltd. (one of the five largest pharmaceutical companies in India *) based in Pune, India. Enzene mainly produces biosimilars, novel biologics, synthetic peptides and phytopharmaceuticals. The company also provides a range of CDMO and CMO services for biologics.

(* according to the latest IQVIA data from MAT from July 2021)

For more information about Enzene Biosciences Ltd. are available from www.enzene.com

For more information about Alkem Laboratories Ltd. are available from www.alkemlabs.com

1 https://www.nhs.uk/conditions/rheumatoid-arthritis/

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