Zydus Cadila Launches World's First Biosimilar Of AbbVie's Humira In India
Published: Dec 09, 2014
December 9, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Biopharmaceutical company Zydus Cadila announced today that it has launched a biosimilar of adalimumab, the world’s largest selling therapy for rheumatoid arthritis and auto immune disorders. This makes it the first company to do so, and the drug will be marketed as Exemptia.
“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,” said Sharvil Patel, the deputy managing director of Zydus Cadila. “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 defined as biological products that are “highly similar” to a reference medicinal product, according to regulatory guidelines. Exemptia can be self-injected, and it works by blocking proteins that contribute to the disease process. In turn, it suppresses certain aspects of the immune system.
Individuals living with conditions such as plaque psoriasis, psoriatic arthritis and rheumatoid arthritis have an excess of tumor necrosis factor, a substance created by the immune system. Exemptia works by reducing levels of the active form of TNF.
AbbVie’s Progress on Humira
AbbVie, the global biopharmaceutical company, has developed adalimumab for the treatment of rheumatoid arthritis, plaque psoriasis, Crohn’s disease, and other immune system disorders. This past September, the company received approval from the U.S. Food and Drug Administration for adalimumab as a form of treatment for Crohn’s disease in pediatric patients.
Adalimumab, which is marketed by AbbVie as HUMIRA, has been proven to reduce symptoms and signs of the condition.
"Moderate to severe Crohn's disease is a serious chronic disorder that can impact children and adolescents in significant ways during this important stage of their lives," said Jeffrey Hyams, head of the Division of Digestive Diseases, Hepatology and Nutrition at the Connecticut Children's Medical Center. "The approval of Humira for this patient population offers a new important treatment option for physicians and their patients that can help address this sometimes debilitating disease."
Both Exemptia and Humira can potentially reduce the body’s ability to fight infection, as it suppresses certain aspects of the immune system.