Mumbai-based Reliance Life Sciences has launched a biosimilar of Roche's ($RHHBY) blockbuster cancer therapy bevacizumab (Avastin) in India--marking a first for the treatment that has been part of a legal tussle and off-label use concerns in the country.
The Drug Controller General of India had earlier approved a biosimilar of bevacizumab to treat colorectal cancer by the company. It will be marketed by Lupin under the name Bevacirel at a price level just shy of the original drug from Swiss-based Roche, according to the Economic Times.
The patented drug has multiple global cancer licenses, including for lung, kidney and ovarian tumors, and made over $6.6 billion last year--making it Roche's second-biggest seller in 2015.
These sales are why the company has been fighting hard against copycats. In May, Roche filed a lawsuit to block approval of a biosimilar of the same drug by Hyderabad-based Hetero Drugs because of the use of language in the packaging label that draws on Roche's own work.
In the case of bevacizumab, the Reliance version was not included in the lawsuit, but biosimilar approval standards in India are a sharp source of intellectual property contentions with multinational drug makers.
Reliance or Roche were not immediately available for comment.
According to the Economic Times, the price gap for the originator version is INR1,200 ($17.97) with the Roche price at INR29,500 for 100mg injection, compared to INR28,300 for the Reliance version.
Earlier this year, off-label use of Avastin in India to treat age-related macular degeneration was linked to partial loss of sight for 15 patients. Roche halted sales during the incident and warned against such use. Sales have since resumed.
- here's the story from the Economic Times