Indian pharmaceutical players, who want to reap a pie of the global biosimilar (copies of biological drugs) markets, are trying their luck at regional markets first.
Players, including Dr Reddy’s, Cipla and Lupin are strengthening their presence in the regional markets such as India and South East Asia with new biosimilar launches. According to statistics released by Datamonitor, the Indian biosimilars market is expected to grow to $580 million by 2012. Biosimilars are generic versions of innovative biotech drugs.
The absence of clear regulatory norms for biosimilars, especially in regulated markets like the US, is a hurdle for generic drug makers. A recent Standard Chartered Bank report, said: “By 2016, eight of the top 10 drugs worldwide are projected to be biologics. By 2015, biologics with an estimated sales value of more than $60 billion are due to lose patent protection, rising to over $100 billion by 2020.” Biotech drugs worth $15 billion sales are expected to go off-patent by 2015 in the US alone, bringing 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 market is a good strategy for Indian companies than entering tough markets such as the US and Europe directly, where 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 FY’02, DRL had launched two more biosimilars — Reditux ((monoclonal antibody for treatment of cancer) in 2008 and Cresp (for anemia) in Q2 FY11. The company plans to launch one more biosimilar in Q4 FY11 and one product each in the coming years.
Entering the league of biosimilar makers, Cipla invested Rs 300 crore last year to acquire stakes in two biotech companies in India and China — MabPharm and BioMab, re spectively. Cipla is expected to launch one oncology-based biosimilar drug by end of FY12 in India. Jaideep Gogtay, medical director, Cipla, did not respond to queries.
“We expect most generics companies to focus currently on emerging markets (including 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 specialty life science company NeuClone Pty Ltd for their cell-line technology, which can be used for developing biosimilars in the oncology space. Lupin is expected to launch its first biosimilar in this segment by 2012.
Cyrus Karkaria, president of Biotechnology, Lupin Ltd, 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 fiscal. 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 Inc for a worldwide commercialisation of four insulin products, with an addressed market of $14 billion.
Under the agreement, Biocon will receive $200 million from Pfizer. “None of the Indian players received a nod from global regulators due to lack of clarity in documentation. Better norms, as far as biosimilar launches are concerned, are expected by end of 2011 in the US,” Dipta Chaudhury added.
