Dr Reddy's Biosimilar Cancer Drug Closer to EU Launch
By Rediff Money Desk, Hyderabad Jul 29, 2024 14:34
Dr Reddy's Laboratories' biosimilar Rituximab, ITUXREDI, receives positive opinion from the European Medicines Agency (EMA), bringing it closer to launch in EU countries.
![Dr Reddy's Biosimilar Cancer Drug Closer to EU Launch](https://im.rediff.com/money/2020/aug/19drug.jpg)
Hyderabad, Jul 29 (PTI) Dr Reddy's Laboratories Ltd on Monday said the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI ) in European markets.
A press release from the city-based drug maker said as part of the established approval process, the CHMP's positive opinion will now be reviewed by the European Commission, following which a decision will be made on the grant of marketing authorisation in the European Union member countries, and the European Economic Area member states of Norway, Iceland, and Liechtenstein.
Dr Reddy's had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad.
A Marketing Authorisation Application for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure, the release said.
DRL_RI is being developed as a biosimilar of Roche's MabThera (Rituximab) which is approved for treatment of certain cancers in the USA, Europe and other countries.
A press release from the city-based drug maker said as part of the established approval process, the CHMP's positive opinion will now be reviewed by the European Commission, following which a decision will be made on the grant of marketing authorisation in the European Union member countries, and the European Economic Area member states of Norway, Iceland, and Liechtenstein.
Dr Reddy's had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad.
A Marketing Authorisation Application for submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure, the release said.
DRL_RI is being developed as a biosimilar of Roche's MabThera (Rituximab) which is approved for treatment of certain cancers in the USA, Europe and other countries.
Source: PTI
Read More On:
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- GTL Infrastructure
- 3.00 ( -0.99)
- 156571997
- Vodafone Idea L
- 16.06 (+ 0.50)
- 58130850
- Khoobsurat
- 1.87 ( 0.00)
- 51842496
- Toyam Sports
- 3.93 (+ 4.80)
- 37849039
- AvanceTechnologies
- 0.94 ( -4.08)
- 33244499
MORE NEWS
![Concor...](https://im.rediff.com/80-80/money/2014/nov/11india8.jpg)
Concor Privatisation Delayed: Govt Puts Sale on...
India's government has put the privatisation of Container Corporation of India (Concor)...
![Power Grid Plans...](https://im.rediff.com/80-80/money/2023/oct/23oct-bse.jpg)
Power Grid Plans Rs 40,000 Crore Subsea...
Power Grid Corporation of India plans to invest Rs 40,000 crore in an undersea...
![India's Coal...](https://im.rediff.com/80-80/money/2022/may/30coal3.jpg)
India's Coal Export Potential: 15 Million...
A study reveals India's potential to export 15 million tonnes of coal to neighbouring...