Zydus Cadila launched the world’s first biosimilar of Adalimumab (Enbrel), the largest selling therapy in the world. This event increases the possibility that the up to 12 million people with immune disorders such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and Ankylosin Spondylitis in India will to have access to treatment.
A biosimilar is a biological product created to be very similar to a reference medicinal product, its originator. This similitude has to follow set US Food and Drug Administration, European Medicines Agency, and CDSCO regulatory guidelines and must have approximated levels of safety and efficacy when compared to its originators, and should be notably more affordable and accessible.
The biosimilar of Adalimumab was developed by a research team at the Zydus Research Centre, was approved by the Drug Controller General of India to address these inflammatory and autoimmune diseases, and will be commercialized as Exemptia. This new formulation of Adalimumab is the first, launched by any company, that has the same safety, potency and purity of its originator. Zydus retains a very robust programme of the largest number of monoclonal antibodies currently being developed in India, including the Adalimumab biosimilar. Their pipeline includes 24 biologics with biosimilars, and 2 new biologics that are being advanced to address autoimmune disorders such as arthritis, stroke, cancer and infertility.
Adalimumab is a fully human anti-TNF alpha monoclonal antibody that achieved global approval in 2002. It is the number one preferred therapy to treat autoimmune disorders, however, it has not been available to the 12 million patients in India that suffer from such chronic conditions that cause lifelong pain and disability.
Dr. Sharvil P. Patel, Director of Zydus Cadila, said in a press release: “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 inIndia 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.”
Exemptia is administrated subcutaneously, once every two weeks, and has been proven to enhance symptom and disease flare control.