Darbepoetin alfa was developed and launched by Amgen in 2001 under the brand name of Aranesp. Annual global sales of darbepoetin alfa in 2009 were US$2.65 billion.

Darbepoetin alfa is a modified version of epoetin alfa, engineered to remain in the blood longer. This results in a reduced dosing frequency simplifying matters for patients compared to treatment of anaemia with epoetin, which is the current standard of care in India.

Vice-Chairman and CEO of Dr Reddy’s, Mr GV Prasad, commented that “Cresp will offer patients in India an improved treatment regimen at affordable pricing … and underscores our commitment to provide affordable and innovative medicines to patients in India”.

Dr Reddy’s expect Cresp to deliver patients savings of up to 28% if they switch from generic epoetin alfa, up to 55% when switching from innovator epoetin alfa (Eprex, Johnson & Johnson) and up to 85% if they switch from innovator darbepoetin alfa (Aranesp, Amgen) to Cresp.

Dr Reddy’s already has two other biosimilars on the market; Grafeel (biosimilar filgrastim) and Reditux (biosimilar rituximab) in India and several other countries. It has a strong pipeline of biosimilars and intends to launch at least one biosimilar a year, according to Mr Prasad.

The company’s pipeline of biosimilars includes a pegylated molecule in late stage clinical trials, two monoclonal antibody products in late stage development, which are scheduled to enter clinical trials, and several others in early stage development.

The global biosimilars market is expected to be worth US$19.4 billion by 2014, growing at a compound annual growth rate of 89% from 2009 to 2014. The Indian biosimilars market in 2008 was worth about US$200 million, and is expected to reach about US$580 million by 2012.

The main factors driving demand in the biosimilars market include increasing user acceptance, low costs and large application area, increasing governmental initiatives and the emerging Indian and Chinese economies. The global biosimilars market is highly fragmented with major players such as Biocon, Dr Reddy’s, Intas, LG LifeSciences, Ranbaxy, Reliance LifeSciences, Sandoz, Teva, and Wockhardt all staking their claims.

References

Dr Reddy’s Press Releases. Dr Reddy’s launches darbepoetin alfa in India under the brand name ‘Cresp®’ - World’s first generic darbepoetin alfa and the only one in India. 09 August 2010.

Amgen 2009 Annual Report and Financial Summary. 23 March 2010.

Dr Reddy’s Laboratories Limited. Annual Report 2009-10.

MarketsandMarkets. Biosimilars (2009 - 2014). 24 September 2009.