Theramex, a global specialty pharmaceutical company dedicated to women’s health, has entered into an agreement with Enzene Biosciences to develop, register and commercialize a biosimilar drug of Roche’s reference medicine RoActemra (Tocilizumab). Tocilizumab, in combination with Methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis. It is planned to be commercialized 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 (RA) 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 (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
  
“Rheumatoid arthritis affects more women than men, so the addition of this biosimilar drug to our existing rheumatology portfolio continues our strategic determination to improve access and affordability of important treatments for women,” said Robert Stewart, CEO, Theramex. “We are excited to expand our focus in rheumatology to now include rheumatoid arthritis to help even more patients with bone diseases and joint pain.”
 
Himanshu Gadgil, director, Enzene, said, “The development of Enzene’s Tocilizumab, through our innovative efforts in the manufacturing of monoclonal antibodies, marks another highlight in a series of endeavors driven by our mission to provide affordable and expanded access to crucial medicines. Our partnership with Theramex bolsters our mission to bring affordable healthcare to patients across the world.”
 
Enzene is an innovation-driven biotech company, a subsidiary of Alkem Laboratories—one of the top five pharmaceutical companies in India, according to IQVIA data—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.