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Humira biosimilar released in India

Published on 18/12/14 at 03:22pm
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Indian firm Zydus Cadila has launched the first biosimilar of AbbVie’s anti-inflammatory medicine Humira, the world’s biggest-selling drug.

Used as a treatment in various forms of arthritis and ankylosing spondylitis – Zydus Cadila’s copy will be branded as Exemptia in India and will cost a fifth of Humira’s (adalimumab) $1,000 per-vial US price.

This will still be too high for many people in India who remain in poverty, but Zydus Cadila has said it will offer a support programme for patients and caregivers and the company still expects sales of at least $16.1 million according to Reuters.

Humira has previously not been available in India – despite 12 million people having conditions that could benefit from it according to the company.

In a statement the Indian firm says that its product is a “‘fingerprint match’ with the originator in terms of safety, purity and potency”. It is also looking into selling the drug in the US and Europe, where Humira’s patents are due to expire in 2016 and 2018 respectively.

Sharvil Patel who is the deputy managing director of Zydus Cadila, tells news source Reuters: "It's a very attractive market. There are many, many companies working on this product."

The looming expiry of Humira has long been a concern for AbbVie. The drug accounts for most of the company’s revenue, bringing in $11.5 billion in sales in 2013 and making up 65% of its total sales in the third quarter of 2014.

It has been searching for a replacement blockbuster or a profitable acquisition, but has little to show for its efforts so far. Most recently the company attempted to buy Irish firm Shire, but was scared off by new US tax laws. It has also partnered with Google’s Calico to develop treatments for age-related diseases and has promising hepatitis C and lung cancer drugs in the pipeline.

Exemptia is unlikely to be the only biosimilar of the drug however. Other companies looking for a share of this lucrative market include Boehringer Ingelheim and Amgen, whose Phase III data appears to support their copy’s equivalency in psoriasis.

Biosimilars are a growing market in India – recently Ranbaxy launched the first biosimilar of Johnson & Johnson’s Remicade (infliximab) in the country.

George Underwood

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