Dr Reddy's application for biosimilar candidate accepted for review by USFDA

Dr Reddy's Laboratories on Wednesday said its biologics licence application for its proposed biosimilar rituximab candidate has been accepted for a substantive review by the US Food and Drug Administration (USFDA). This closely follows acceptance of the rituximab biosimilar dossier 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 milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets," Dr Reddy's Global Head of Biologics Jayanth Sridhar said in a statement.

It also reinforces the potential of the product as a safe and effective treatment option for patients across the globe, he added.

Development and commercialisation of biological drugs is an important growth lever for the company's business, Sridhar noted.

"We expect to bring many more biosimilar and other critical biological products to meet patient needs as we work towards our goal of serving over 1.5 billion patients by 2030," Sridhar said.

Dr Reddy's rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets.

The company is currently collaborating with Fresenius Kabi, a global healthcare company, to commercialise the proposed biosimilar of rituximab in the US.

The Hyderabad-based company intends to commercialise the product in Europe and other geographies directly, it added.