Developed by the researchers at the Zydus Research Centre, the adalimumab biosimilar has been approved by the Drug Controller General of India and will be marketed under the brand name Exemptia to treat autoimmune disorders such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and Ankylosing Spondylitis.
Zydus, which is the 8th largest generics company in the US in terms of prescriptions, claims the new anti-inflammatory is a “fingerprint match” with the originator in terms of safety, purity and potency, though the company has not disclosed if the treatment underwent Phase III testing. The biosimilar is one of the company’s 24 developing biosimilars, which it claims represents the largest number of monoclonal antibodies under development in India.
Zydus also says it expects to make about $16m off of the biosimilar over the next three years, which would be a significant boost to the company, which made about $45m in profit last quarter.
Media reports are also claiming the Zydus biosimilar will cost one-fifth of the price of Humira in the US, where monthly treatment can cost more than $1,500. The cost savings may come partly from the company’s decision to manufacture the biosimilar in-house.
The development comes just a week after India saw the launch of its first biosimilar, with Ranbaxy launching the first Remicade biosimilar on the subcontinent.
But Zydus will face stiff competition in Western markets from other biosimilars, especially with Amgen claiming back in October that its Humira biosimilar met its endpoints in the first of two planned Phase III trials. Sandoz, Momenta and Coherus also have Humira biosimilars in their pipelines.