Hyderabad-based Hetero Drugs has launched a biosimilar of Roche's ($RHHBY) colorectal cancer therapy Avastin (bevacizumab) in India, apparently overcoming a legal challenge by the Big Pharma linked to language on the packaging label that draws on the originator’s clinical work.
The launch, according to Press Trust of India, will see the product called Cizumab available in a single dose vial strengths of 100 and 400 milligrams. The Drug Controller General of India (DGCI) approved the biosimilar version by Hetero as well as one by Mumbai-based Reliance Life Sciences launched earlier in June--the first biosimilar version in India.
The Reliance version, which will be marketed by Mumbai-based Lupin under the name Bevacirel, comes at a price level just shy of the original drug in India with a price gap of INR1,200 ($17.97) for a 100mg injection. Pricing information was unavailable for the Hetero version.
At least one other company, Ahmedabad-based Intas Pharmaceutical, has an application for a version of bevacizumab pending before the DCGI.
In May, Roche filed a lawsuit to block approval of a biosimilar of the same drug by Hetero, citing the labeling description of clinical outcomes.
- here's the story from Press Trust of India