Dr. Reddy's Launches World's First Aranesp Biosimilar In India, Vows To Bring Out More
This article was originally published in The Pink Sheet Daily
Executive Summary
The Indian drug maker has officially kept its biosimilar pipeline secret but has indicated that it includes a pegylated molecule in late-stage clinical trials, two other products scheduled to enter clinical trials, and several others in early stage development.
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MUMBAI - Dr. Reddy's Labs has become the world's first company to launch a generic version of Amgen's erythropoiesis-stimulating agent Aranesp (darbepoetin alfa). The biosimilar, called Cresp , has been approved in India for the treatment of anemia due to chronic kidney disease and anemia due to chemotherapy, Dr. Reddy's announced Aug. 9. Aranesp was first launched in 2001 by Amgen, and a decade later the company records global sale of $2.65 billion, of which $1.25 billion comes from the U.S. alone. Dr. Reddy's has a track record of launching first-to-market biosimilars. The Hyderabad, India-based company was the first to bring out a generic version of filgrastim (Amgen's Neupogen ) and branded it as Grafeel . It repeated the feat in 2007 with the launch of the first biosimilar of Genentech's Rituxan (rituximab), branded as Reditux, for the treatment of non-Hodgkin's lymphoma. Reditux remains the only marketed biosimilar monoclonal antibody in the world. "Dr. Reddy's will be launching Cresp in both vials and pre-filled syringes," the company said in a statement. Dr. Reddy's Vice-Chairman and Chief Executive G. V. Prasad commented, "Cresp will offer patients in India an improved treatment regimen at affordable pricing. The launch of Cresp by Dr. Reddy's is a significant step in redefining the treatment of anemia in India and underscores our commitment to provide affordable and innovative medicines to patients in India." More Biosimilars On The Way? Cartikeya Reddy, who heads the biologics operations for Dr. Reddy's, said, "Cresp offers convenient dosing, predictable rise and excellent long term control of hemoglobin." Reddy is a former Genentech executive and is said to be working on at least eight biosimilars for Dr. Reddy's. Dr. Reddy's has officially kept its pipeline of biosimilars secret, but indicated that it includes a pegylated molecule in late-stage clinical trials, two other products in late-stage development that are scheduled to enter clinical trials, and several others in early stage development (Also see "India's Dr. Reddy's Has All Guns Blazing On Biosimilars; Plans To Go After Top 10" - Scrip, 21 Dec, 2009.). In India, Eprex is the originator brand of epoetin, marketed by Johnson & Johnson. Though highly genericized, Eprex commands a premium price in India. Dr. Reddy's noted that Cresp has been priced to offer significant monthly savings to patients when compared to Eprex and other biosimilars of epoetin available in the Indian market. The India approval notwithstanding, ESAs have come under increased scrutiny by global regulators in recent years, after studies found that the drugs accelerate tumor growth and result in earlier deaths in some cancer patients. In February, U.S. FDA implemented a Risk Evaluation and Mitigation Strategy for Aranesp and J&J's Procrit that requires health care professionals to educate patients about the risks and benefits of treatment, but stops short of more restrictive REMS options such as patient registries or limits of use (Also see "ESA REMS Allows Oncology Providers One Year To Enroll Before Possible Distribution Limits" - Pink Sheet, 16 Feb, 2010.). -Vikas Dandekar ([email protected]) [Editor's note: This article appears courtesy of PharmAsiaNews.com , Elsevier Business Intelligence's source for Asian biotech and pharmaceutical news. Register for a 30-day risk free trial. PharmAsia News will host the 2nd PharmAsia Summit: Taking the Risk Out of Asia Oct. 25-26 in San Francisco. For a list of speakers and topics, click here.] |