Many Indian pharmaceutical companies wishing to get part of the global biosimilar (copies of biological drugs) market are first trying their luck closer home. Dr Reddy’s, Cipla and Lupin are strengthening their presence in the Indian market and in Southeast Asia, with new biosimilar launches. According to statistics from Datamonitor, the Indian biosimilars market is expected to grow to $580 million (Rs 2,580 crore) by 2012.
The absence of clear regulatory norms for biosimilars, especially in regulated markets like the US, is the hurdle for generic drug makers. A recent Standard Chartered Bank report, said, “By 2015, biologics with an estimated sales value of $60 billion are due to lose patent protection, rising to $100 bn by 2020.” Biotech drugs worth $15 bn in sales are expected to go off-patent by 2015 in the US alone, a huge opportunity for generic players worldwide.
Dipta Chaudhury, senior consultant, pharma & biotech, South Asia and Middle East, Frost & Sullivan, said, “Improvising skills through biosimilar launches in regional markets is a good strategy for Indian companies than entering the tough markets like the US and Europe directly, where the risk is higher.”
Among the Indian companies, Dr Reddy’s Labs (DRL) leads the list with a strong biosimilar pipeline. Started with the launch of Grafeel for cancer in 2001-02, DRL had launched two more — Reditux (monoclonal antibody for treatment of cancer) in 2008, and Cresp (for anaemia) in the second quarter of 2010-11. The company plans to launch one more biosimilar in the fourth quarter of this year and one product each in the coming years in India.
Entering the league of biosimilar makers, Cipla invested Rs 300 crore last year to acquire stakes in two biotech companies in India and China, named MabPharm, and BioMab, respectively. It is expected to launch one oncology-based biosimilar drug by the end of 2011-12 in India.
EASIER NORMS
“Most generics companies are expected to focus currently on emerging markets (including markets like India) for product launches, as regulatory pathways are cleaner in these markets, with incremental strategies for markets like the EU,” the report said.
Last month, Lupin had signed a pact with Sydney-based private speciality life science company NeuClone Pty Ltd for their cell line technology, which can be used for developing biosimilars in oncology. Lupin is expected to launch its first biosimilar in oncology by 2012.
Cyrus Karkaria, president - biotechnology, Lupin, said, “We currently have eight proteins in different stages of development, with two of the most advanced products about to commence clinical trials. We are now looking to launch our first biological in the Indian market by next year. We expect five per cent of our business in the next five years to come from our biotech business.”
In October 2010, Biocon, the country’s largest biotech drug maker, had forged a strategic deal with Pfizer for worldwide commercialisation of four insulin products, with an addressed market of $14 bn. Under the agreement, Biocon will receive $200 mn from Pfizer.
