Hetero launches Avastin biosimilar in India

Hyderabad: Hetero Drugs Ltd on Monday said it has launched a biosimilar version of Roche AG’s cancer drug Avastin in India.

Avastin or bevacizumab, as it is generically called, is used for the treatment of metastatic colorectal cancer (mCRC).

The product, which was launched under brand name Cizumab, has been approved by Drug Controller General of India (DCGI) and has been recommended as a first-line of treatment for mCRC.

“The product will be made available to patients in a single dose vial with two strengths, 100 mg and 400 mg,” Hetero said in a statement.

It will be marketed and distributed by Hetero Healthcare Ltd, a group company of Hetero.

“Bevacizumab is the third product in our biologics portfolio, after Darbepoetin alfa and Rituximab,” said B.P.S. Reddy, chairman and managing director of Hetero.

“We believe Cizumab will be a cost-effective treatment option to patients in India,” Reddy said.

Hetero didn’t disclose the price of the drug. Roche sells Avastin at ₹ 29,500 for a 100mg injection.

Hetero said bevacizumab will be manufactured at its Hyderabad facility.

DCGI in earlier June allowed Mumbai-based Reliance Life Sciences Pvt. Ltd to launch the biosimilar version of bevacizumab.

The launches by Reliance Life Sciences and Hetero were delayed due to a legal challenge from Roche.

Ahmedabad-based Intas Pharma’s bevacizumab is also pending for approval before DCGI.

Roche’s Avastin has multiple global cancer licences, including for kidney, lung and ovarian tumors, and made over $6.6 billion, globally making it Roche’s second-biggest seller in 2015.

A biosimilar product is a complex biological product that follows a different approval pathway compared to chemical drugs. Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.