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India court grants Herceptin injunction

Published on 10/02/14 at 11:15am

Roche has been granted an injunction by a court in India to prevent generic manufacturers of its ageing breast cancer drug Herceptin from comparing their products to the brand in marketing campaigns.

An order from the Delhi High Court says Biocon and Mylan, which co-developed CANMAb and Hertraz, states they are “restrained from relying upon or otherwise referring to Herceptin”.

This includes data relating to its manufacturing process, safety, efficacy and sales in any press releases, public announcements, promotional or other material.

Above all, the judgment means the companies are also prevented from claiming any similarity between their breast cancer treatments and Herceptin (trastuzumab).

In a statement, Biocon described the decision as ‘extremely shocking, but not unexpected’. The company received marketing authorisation from the Drugs Controller General of India (DCGI) for its biosimilar in November.

“This proceeding is an attempt by Roche to protect their market monopoly and prevent Indian patients from accessing a more affordable trastuzumab,” the firm insisted.

But it was bullish about its prospects, adding: “We are confident that once we are heard by the court, this injunction placing certain limits on promotional activities will not stand.”

In August, Roche said it would not be pursuing its Indian patent application for Herceptin, even though it was expected to last until 2019, thus opening the door for cheaper copies in the country.

Herceptin was Roche’s third best-selling drug in 2013, with global sales of £4.1 billion, up 6% on 2012.

But the erosion of the brand’s exclusivity is unlikely to have a significant impact on the biotech giant’s bottom line, as the Indian market accounted for just £62.6 million in global sales last year - although this was a 59% increase on 2012.

Herceptin received its first approval from the US Food and Drug Administration in 1998 for the treatment of metastatic breast cancer - and the bigger problem for Roche will be the end of Herceptin’s patent in the US and Europe, which will start in around five years’ time.

In India, the Swiss firm has set up a deal with Indian manufacturer Emcure Pharmaceuticals to sell what it calls an ‘off-brand’ version of the drug, known locally as Herclon.

The size of its population and emerging economy makes India potentially attractive for drug makers, with companies finding their own ways into the market there.

Gilead last week announced the unusual step of allowing its new and highly expensive hepatitis C pill Sovaldi (sofosbuvir) to be sold as a cheaper generic in the country.

Adam Hill

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