Zydus Cadila has become world’s first company to launch the biosimilar of Adalimumab, the fully human anti-TNF alpha monoclonal antibody, for treating rheumatoid arthritis and other auto immune disorders in India.Developed by the researchers at the Zydus Research Centre, 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 Adalimumab and a novel non-infringing formulation hasbeen researched, developed and produced by scientists at the Zydus Research Centre. Exemptia is a ‘fingerprint match’ with the originator in terms of safety, purity and potency of the product. The biosimilar of Adalimumab is a part of Zydus’ robust biologics programme which has the largest number of monoclonal antibodies under development in India. The group’s 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.
Adalimumab 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.
Dr Sharvil Patel, deputy managing director of 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 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 referencemedicinal products (originator products) following the European Medicines Agency (EMA), US Food and Drug Administration (USFDA) and the CDSCO 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.
The therapy will be marketed by Zydus Biovation- a new division launched toexclusively market this ground breaking therapy.
This novel non-infringing process for Adalimumab and a novel non-infringing formulation hasbeen researched, developed and produced by scientists at the Zydus Research Centre. Exemptia is a ‘fingerprint match’ with the originator in terms of safety, purity and potency of the product. The biosimilar of Adalimumab is a part of Zydus’ robust biologics programme which has the largest number of monoclonal antibodies under development in India. The group’s 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.
Adalimumab 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.
Dr Sharvil Patel, deputy managing director of 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 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 referencemedicinal products (originator products) following the European Medicines Agency (EMA), US Food and Drug Administration (USFDA) and the CDSCO 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.
The therapy will be marketed by Zydus Biovation- a new division launched toexclusively market this ground breaking therapy.