Reddy’s Laboratories on Tuesday said it is foraying into the biosimilar immuno-oncology therapy segment in India with the launch of Nivorz, a biosimilar of Bristol Myers Squibb’s Opdivo (nivolumab). Dr.
“The launch of Nivorz strengthens our oncology portfolio and expands presence in immuno-oncology. As access to immunotherapy continues to be a challenge for many patients, we remain committed to improving access to high-quality treatment options through affordable biosimilars,” CEO Global Generics M.V. Based on this clinical development programme, it has been approved in India by the Drugs Controller General of India (DCGI). Nivorz is one of the immunotherapy agents with the broadest range of approved indications in oncology in India.
The company said Nivorz was evaluated through a multi-country clinical development programme involving 288 patients, including 252 from India and 36 from Russia, and demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference nivolumab.
Ramana said. The approved indications span early-stage, locally advanced, recurrent and metastatic disease settings across both solid and hematological malignancies, the company said.
