New Delhi: Zydus Cadila on Tuesday announced the launch of Exemptia, “the world’s first” biosimilar of Adalimumab, to treat auto immune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosing Spondylitis.
Developed by the researchers at the Zydus Research Centre, Exemptia has been approved by the Drug Controller General of India (DCGI), according to a statement by Zydus Cadila.
The biosimilar is the first to be launched by any company in the world and is a ‘fingerprint match’ with the originator in terms of safety, purity and potency of the product, the statement said.
Adalimumab (trade name Humira, which is marketed by AbbVie), the fully human anti-TNF alpha monoclonal antibody, was first approved globally in 2002 and has since then been the most preferred therapy to treat patients suffering from auto immune disorders.
However, the therapy (Adalimumab) was not available to patients in India. It is estimated that more than 12 million patients in India suffer from these chronic conditions (auto immune disorders), which progressively deteriorate and lead to lifelong pain and in some cases, even disability.
Sharvil P Patel, deputy managing director, Zydus Cadila, said, “This therapy will offer a new lease of life to millions in India who did not have access to this therapy so far. We are happy to offer them hope, freedom from pain and better quality of life through Exemptia.”
Biosimilars are biological products that are ‘similar’ or ‘highly similar’ to the reference medicinal products (originator products) following the EMA (European Medicines Agency), US FDA (Food and Drug Administration) and the CDSCO (Central Drugs Standard Control Organization) regulatory guidelines. Biosimilars have similar level of efficacy and safety compared to that of the originator products and provide additional advantage to patients in terms of affordability and accessibility.
Exemptia is given as a 40 mg subcutaneous injection once every alternate 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 – which means the auto immune disorder is under control and the patient is able to live a life without pain and can actually lead a fully active life.
Zydus will offer a dedicated Exemptia Care support programme to patients and caregivers. The programme shall provide important support and information regarding access, adherence, awareness and thereby help patients to appropriately manage their disease, the statement said.
Exemptia will be marketed by Zydus Biovation — a new division launched to exclusively market this therapy.
According to Zydus, the biosimilar of Adalimumab is a part of its robust biologics programme which has the largest number of monoclonal antibodies under development in India. The group’s research and development (R&D) pipeline, which comprises 24 biologics, includes biosimilars and three novel biologics. These biologics are being developed to treat auto immune disorders like arthritis, cancer, infertility and stroke.