Dr Reddy’s application for biosimilar candidate accepted for USFDA’s review

Dr. Reddy’s laboratories said Wednesday that a biosimilar authorization application for a proposed biosimilar rituximab candidate has been accepted for substantive review by the U.S. Food and Drug Administration (USFDA).

This comes after biosimilar rituximab was accepted for review by two other regulatory agencies – the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Rituximab is used to treat certain autoimmune diseases and types of cancer. “This achievement underscores our ability to globally develop high-quality biosimilar products for highly regulated global markets,” Gyanth Sridhar, global lead biosimilars Dr. Reddy, said in a statement.

He added that it also enhances the potential of the product as a safe and effective treatment option for patients around the world.

Sridhar noted that the development and commercialization of biological medicines is an important growth lever for the company’s business.

“We expect to bring in more biosimilars and other vital biological products to meet patients’ needs as we work toward our goal of serving more than 1.5 billion patients by 2030,” Sridhar said.

Dr. Reddy’s biosimilar variant rituximab is approved for marketing in India and over 25 emerging markets.

The company is currently collaborating with Fresenius Kabi, a global healthcare company, to market the proposed biosimilar to rituximab in the United States.

She added that the company, which is based in Hyderabad, intends to market the product in Europe and other geographical areas directly.