Betting big on biosimilars or follow-on biologics, Dr Reddy’s Laboratories is gearing up to become the largest biosimilar company by tapping the emerging markets. Biosimilars or follow-on biologics are products that are marketed after expiration of patents and claim to have similar properties to existing biologic products.
The company has lined up eight more biosimilar products which are in various stages of development for an investment of Rs 30-40 crore. The company currently markets Grafeel (biosimilar filgrastim) and Reditux (biosimilar rituximab) in India and several other countries.
According to Cartikeya Reddy, senior vice-president and head of Biologics, the company’s pipeline of biosimilars includes a pegylated molecule in late stage clinical trials, two products in minoclonal antibodies which are in late stage development and scheduled to enter clinical trials and several others in early stage development. ?With an initial capex of Rs 150 crore for creating capacities, we would be exploring other emerging markets for biosimilars,? he said after launching Cresp, which is the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India.
The company plans to launch at least one product in a year. Cresp has been approved in India for the treatment of anemia caused due to chronic kidney disease and anemia due to chemotherapy. Creap is claimed to be 55% cheaper than the available epoetin drug. The drug is valued at Rs 150 crore. The company needs fresh approval to market in other countries.
The global biosimilars market is expected to be worth $19.4 billion by 2014, growing at a CAGR of 89.1% from 2009 to 2014. The biosimilars market is segmented into peptides, recombinant glycosylated proteins, recombinant non-glycosylated proteins, and others. The Indian biosimilars market in 2008 was about $200 million, with an expectation to reach about $580 million by 2012. While there is an opportunity in the emerging markets, the regulatory pathway is still not developed in the developed markets for biosimilars, company officials added.
The factors driving the demand in 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 Lab, Intas, LG LifeSciences, Ranbaxy, Reliance LifeSciences, Sandoz, Teva, and Wockhardt.