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India firm launches biosimilar for autoimmune disease

10 December 2014 | News | By BioSpectrum Bureau

India firm launches biosimilar for autoimmune disease

Biosimilars are biological products that are exactly similar to the reference medicinal products

Biosimilars are biological products that are exactly similar to the reference medicinal products

Singapore: India-based Zydus Cadila has launched the biosimilar of Adalimumab, indicated for the treatment of auto immune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosing Spondylitis

The biosimilar is approved by Drug Controller General of India and will be marketed under the brand name Exemptia, to treat auto immune disorders. According to Zydus Cadila, the biosimilar is the exact 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 been the most preferred therapy to treat patients suffering from auto immune disorders.

Dr Sharvil P Patel, deputy managing director, Zydus Cadila, 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."

Biosimilars are biological products that are exactly similar to the reference medicinal products (originator products) following the EMA (European Medicines Agency), FDA (Food and Drug Administration, USA) and the CDSCO regulatory guidelines. Biosimilars have a 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.

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