Adalimumab is the world's largest-selling drug and posted sales of nearly $11 billion last year.
Developed by Zydus Research Centre, the biosimilar has been approved by the Drug Controller General of India and will be marketed under brand name Exemptia at a cost that will be one-fifth of the innovator brand Humira by AbbVie.The cost of the innovator drug by AbbVie is $1,000 per vial. Exemptia will be available at $200 per vial.
Biosimilars are biological products that are similar or highly similar to the reference medicinal products (originator products). Biosimilars have similar level of efficacy and safety compared with the originator products and provide an additional advantage to patients in terms of affordability and accessibility.
In a press statement, Zydus Cadila said it had become the first company in the world to launch the biosimilar of adalimumab. It added that the drug was developed using a novel non-infringing process.
It is estimated that more than 12 million patients in India suffer from these chronic conditions that include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis, which progressively deteriorate and and in some cases lead to disability.
'This therapy will offer a new lease of life to millions in India. We are happy to offer them hope, freedom from pain and better quality of life through Exemptia,' deputy managing director of Zydus Cadila Sharvil P. Patel said.
The group's R&D pipeline comprises 24 biologics that cover biosimilars and three novel biologics. These biologics (drugs produced by using living cells) are being developed to treat auto immune disorders such as arthritis, cancer, infertility and stroke.
