Dr Reddy's Biosimilar Rituximab Accepted for Review by USFDA, EMA, and MHRA

13 Jul 2023 , 11:53 AM

Dr Reddy’s Laboratories has announced that the biologics license application for its proposed biosimilar rituximab has been accepted for a substantive review by the US Food and Drug Administration (USFDA).

This acceptance follows the review acceptance of the rituximab biosimilar dossier by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Rituximab is a medication used to treat autoimmune diseases and certain types of cancer. Dr Reddy’s Global Head of Biologics, Jayanth Sridhar, stated that this milestone highlights the company’s capability in global clinical development of high-quality biosimilar products.

The acceptance reinforces the potential of the rituximab biosimilar as a safe and effective treatment option for patients worldwide. Dr Reddy’s considers the development and commercialization of biological drugs as an essential growth lever for its business.

The company aims to serve over 1.5 billion patients by 2030 by bringing more biosimilar and critical biological products.

Dr Reddy’s rituximab biosimilar has already received marketing approval in India and over 25 emerging markets. In the US, the company is collaborating with Fresenius Kabi for the commercialization of the rituximab biosimilar. Dr Reddy’s plans to directly commercialize the product in Europe and other regions.

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