Zydus Cadila is the first company to launch a biosimilar of Amgen’s Adalimumab, a top selling therapy for rheumatoid arthritis and other autoimmune disorders. The biosimilar has been approved by the Drug Controller General of India and will be marketed under the brand name Exemptia, to treat autoimmune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosing Spondylitis.
 
The new process and formulation of Adalimumab have been researched, developed and produced by Zydus Research Centre. The group’s R&D pipeline comprises 24 biologics, including biosimilars and three novel biologics. These biologics are being developed to treat autoimmune disorders like arthritis, cancer, infertility and stroke.
 
Adalimumab, the fully human anti-TNF alpha monoclonal antibody, was first approved globally in 2002, however, was not available to patients in India. It’s estimated that more than 12 million patients in India suffer from these chronic conditions.
 
Exemptia is given as a 40 mg subcutaneous injection once every other week. Patients normally would have to take the treatment for six months. It has been clinically observed that the therapy is able to arrest the degeneration and the patient goes into remission.
 
Deputy managing director of Zydus Cadila, Dr. Sharvil P. Patel said, “At Zydus, we believe that innovations must bridge unmet healthcare needs and provide solutions to patients who are suffering from disease and disability especially in such chronic conditions. This therapy will offer a new lease of life to millions in India who have not had access to this therapy so far. We are happy to offer them hope, freedom from pain and a better quality of life through Exemptia.”