Zydus Cadila launches biosimilar adalimumab in India

December 10, 2014 11:12 AM

Zydus Cadila becomes the first company in the world to launch the biosimilar of adalimumab – the world’s largest selling therapy.

According to Zydus Cadila, the biosimilar has been approved by the Drug Controller General of India and will be marketed under the brand name, Exemptia to treat auto immune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis.

This novel non-infringing process for AbbVie’s Humira (adalimumab) and a novel non-infringing formulation has been researched, developed and produced by scientists at the Zydus Research Centre. 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.

Adalimumab, 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 was not available to patients in India. It is estimated that more than 12 million patients in India suffer from these chronic conditions which progressively deteriorate and lead to lifelong pain and in some cases, even disability.

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 therapy will be marketed by Zydus Biovation – a new division launched to exclusively market this ground breaking therapy.


Source: Zydus Cadila press release

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