Dr Reddy's aims to be a Biosimilar leader

GV Prasad, vice chairman and CEO, DRL with Satish Reddy, COO, DRL

Hyderabad-based, Dr Reddy's Laboratories, the $1.2 billion Indian pharma major, and one of the world's leading generics players, is making determined efforts to increase its portfolio of biosimilar products and become a global leader in the next decade in this space. A special report from the company's Hyderabad campus.

After conquering the pharma generics space, as one of the world's Top 10 players, Dr Reddy's Laboratories (DRL), has turned its attention to repeat the success story in the biologicals arena. "We want to be the world's No.1 biosimilar company. And we would like to introduce one new product every year and we are looking at a portfolio of 15 to 20 products," summed up DRL's Vice Chairman and CEO, GV Prasad, while interacting with a select group of journalists at the company's corporate headquarters in Hyderabad recently.

It is a tough task but the company is going ahead with its customary zeal to enhance its presence in the biotech arena. A biotech expert, Cartikeya Reddy, Vice President, is spearheading the biologicals thrust with a scientific team exceeding 100 members and new facilities and capacity expansions are going on at a furious pace in the company's manufacturing complex on the outskirts of Hyderabad. The company has invested over $30 million in its biologicals facility so far.

DRL has so far launched two biological products, Grafeel (a Filigrastim) and Reditux (biosimilar version of Rituximab) which is the world's first monoclonal anti-body based anti-cancer drug.

Prasad is aware of the challenges in the biosimilar area, where the regulatory rules in the two most important markets of the world--US and Europe--are not yet clear. "It is a big game. It will cost at least $20 million to take a biosimilar drug to the European market. It takes only a small fraction of that amount for a conventional generics pharma product," Prasad explained.

The company is looking at introducing these products in the European markets in the next three-four years, buoyed by the guidelines on biosimilars announced by the regulatory agency there. DRL is planning to generate clinical trial data in Europe soon.

DRL is planning to increase its portfolio of biosimilars. It is eyeing some of the eight biotech drugs which have not been patented in India.

Focus areas

At the strategy level, DRL is increasing its focus on innovation and has identified four major areas. Its drug discovery and research efforts, Prasad said, are concentrated in oncology, metabolic disorders such as diabetes, cardiovascular diseases and infectious diseases.

Prasad said the company will redouble the efforts to meet its mission to provide affordable healthcare through alternatives to expensive, branded pharma products. Innovation to meet the unmet medical needs will be the thrust area for the company.

DRL's COO Satish Reddy said the company was trying its best to increase its presence in new geographies. Market exploration was going on in Japan and its presence may be increased in the Australian and New Zealand markets. The company is also increasing its focus on Mexico and many tender-based markets. "If you want to be a global generics player, you have to take these chances," Reddy said.

DRL has got the approval to set up a 250-acre Special Economic Zone focused on pharma products in Hyderabad. The SEZ will specialize in the manufacture of bulk drugs and formulations.

DRL has been elated by the recent visit of the US Health Minister (Secretary for Health and Human Services), Michael Levitt, and inspection of its manufacturing facilities in Hyderabad. DRL has one of the largest Active Pharmaceutical Ingredient (API) manufacturing facilities in the Asia-Pacific region.

By N Suresh in Hyderabad