Patients in India will finally have access to a version of the world’s biggest selling drug Humira with the launch of its first biosimilar.
Indian company Zydus Cadila launched its copy of AbbVie’s Humira (adalimumab) earlier this month for use in all of the drug’s approved autoimmune indications, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis.
The news will be welcomed by the estimated 12 million people in India who have one or more of these conditions but have been unable to receive treatment with Humira as the drug is not available in the country.
Zydus Cadila’s drug, which will be sold under the name Exemptia, is the first of what is likely to be several biosimilar versions of Humira to be launched in the next couple of years as the drug’s patents expire across the world.
The situation is serious for AbbVie as the bulk of the company’s revenues come from Humira, which has been the world’s biggest selling prescription medicine for two years in a row and took in $11.5bn during 2013.
The onset of cheaper biosimilar versions will hit these revenues hard forcing AbbVie to rely on newer products, such as its hepatitis C combination and its oncology pipeline.
Regarding the distribution of Exemptia in India Zydus Cadila said it will offer a dedicated support programme for patients and caregivers which will provide support and information regarding access, adherence and awareness.
Zydus Cadila will create a new division – Zydus Biovation – to market the drug. This new business will support the drug’s launch with a series of medical education events and scientific symposia for healthcare professionals in India.
Deputy managing director of Zydus Cadila, Dr Sharvil Patel said: “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.”
Other companies with ambitions to launch a biosimilar version of Humira include Amgen, which has posted phase III data backing the drug’s equivalency in psoriasis.
Boehringer Ingelheim is also working on a biosimilar Humira in addition to biosimilar versions of Lantus, Avastin and MabThera/Rituxan.