Therapy Areas: Autoimmune
Theramex Inks Agreement with Enzene Biosciences Ltd. for the Development and Commercialisation of Tocilizumab, a Biosimilar for the Treatment of Rheumatoid Arthritis
27 December 2021 - - UK-based speciality pharmaceutical company Theramex has entered into an agreement with Enzene Biosciences Ltd. to develop, register and commercialise a biosimilar drug of Switzerland-based Roche's reference medicine RoActemra (Tocilizumab), the company said.

Tocilizumab, in combination with Methotrexate, is indicated for the treatment of rheumatoid arthritis.

It is planned to be commercialised from 2026 in Europe, the UK, Switzerland, and Australia.
Theramex's Tocilizumab product will be available in parenteral vials, subcutaneous prefilled syringes and autoinjectors.

The reference product RoActemra is indicated for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate; moderate to severe RA adult patients who have not responded well/intolerant to DMARDs or Anti-TNFs; active systemic juvenile idiopathic arthritis in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids; juvenile idiopathic polyarthritis in patients 2 years of age and older unresponsive to MTX; treatment of Giant Cell Arteritis in adults; and chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome in adults and paediatric patients 2 years of age and older.

Rheumatoid arthritis is a chronic condition that causes pain, swelling and stiffness in the joints. The condition usually affects the hands, feet and wrists.

There may be periods where symptoms become worse, known as flares. A flare can be difficult to predict, but with treatment it's possible to decrease the number of flares and minimise or prevent long-term damage to the joints.

Some people with rheumatoid arthritis also experience problems in other parts of the body, or more general symptoms such as tiredness and weight loss.

Theramex is a global speciality pharmaceutical company dedicated to women and their health. We support women at every stage of their lives by providing a portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis.

Enzene is a biotechnology company, a subsidiary of Alkem Laboratories Ltd. (One of the top five pharmaceutical companies in India) located in Pune, India.

Enzene's focus lies in producing biosimilars, novel biologics, synthetic peptides and phytopharmaceuticals. Enzene also offers a range of biologics CDMO and CMO services.
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