1 month ago
Dr Reddy’s Secures FDA Approval for Rituximab Biosimilar
Dr Reddy’s Laboratories, a big Indian drug company, got the US Food and Drug Administration’s green light for a new version of a cancer medicine called rituximab.
This means the company can sell the drug in the United States.
A German company, Fresenius Kabi, will handle selling it in the US.
The drug was made and tested entirely by Dr Reddy’s in their Hyderabad plant.
The approval shows the company can make complex medicines that meet strict US rules.
The drug is already sold in many other countries, like India, the EU, the UK, Canada, and Switzerland.
Dr Reddy’s Laboratories received FDA approval for its rituximab biosimilar.
Fresenius Kabi will exclusively commercialise the product in the United States.
The biosimilar was developed, manufactured and filed entirely in-house by Dr Reddy’s.
The approval followed a successful FDA pre‑license inspection of the Hyderabad facility.
The drug is already sold in India, the EU, the UK, Canada, Switzerland, and other markets.
- Who
- Dr Reddy’s Laboratories, an Indian pharmaceutical company
- What
- Received US FDA approval for its rituximab biosimilar
- Where
- United States (FDA approval) and Hyderabad, India (manufacturing facility)
- When
- Why
- To enter the US market and expand its biosimilar portfolio
Key facts
- Company
- Dr Reddy’s Laboratories
- Product
- Rituximab biosimilar
- Approval Authority
- US FDA
- Commercialiser in US
- Fresenius Kabi
- Existing Markets
- India, EU, UK, Canada, Switzerland
Quotes
Sridevi Khambhampaty
Global Head of Biologics at Dr Reddy’s Laboratories
“"The approval of the rituximab biosimilar on the FDA’s goal date reflects our capabilities in developing and manufacturing complex biologic medicines for global markets."”
financialexpress.com
Sources
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