Intas Biopharmaceuticals Limited (IBPL) is focusing on on developing biosimilars and second-generation products (superior generics) for regulated markets of Europe and US after having established its presence in India and other semi-regulated markets.
Biosimilars or follow-on biologics refer to officially approved new versions of innovator biopharmaceutical products, following patent expiry.
Intas has a biosimilar product pipeline that covers wide spectrum of oncology products covering solid tumours, haematological malignancies and supportive therapies, said Rustom Mody, chief scientific officer and director (Quality), IBPL. It is already present in around 70 semi-regulated markets and has plans to launch its entire range of biotech products in regions like South-East Asia, Latin America, CIS & Russia and Africa in the near future.
The European biopharmaceuticals market currently accounts for approximately 45 per cent of the global market, and is expected to grow at over 10 per cent over a period of time. "The number of biosimilars in the European and US markets are set to increase, as it is one of the most lucrative markets. Globally, payers’ perception of biosimilars, as viable alternatives to originator drugs due to their safety, efficacy and affordability, will further bolster market prospects.", Mody claimed adding that in Europe, the market potential coupled with the entry barrier for low cost companies motivates us to have our focus.
"Our strategy would be a step-wise approach from active pharmaceutical ingredients (API) to biosimilars to contract research to collaborative research & bio-betters to novel biologics. The company is aiming to replicate its biosimilar success of India and semi-regulated markets in Europe & UK.", Mody explained.
The global biosimilars market is growing at a CAGR of 89.1 per cent from 2009 to 2014 to reach an estimated $19.4 billion in 2014.
As for India, IBPL has committed an investment of around Rs 160 crore towards setting up of a separate manufacturing facility for Monoclonal Antibodies during the Vibrant Gujarat Summit of 2009. Despite high therapy costs and drug format limitations, the popularity of monoclonal antibodies (MAbs) is on the rise as physicians are increasingly adopting MAbs for their superior side effect profile, and continued research is expected to yield more innovative products, said an Intas spokesperson.
It has acquired 23,000 square meter of land at the Matoda village in Sanand and is in the process of getting government clearances. The facility, dedicated for Monoclonal Antibodies, will undertake large-scale manufacturing of the recombinant product with a capacity of 5000 litres in phases. It is likely to go onstream in 2012, the spokespeson said.