While over 50 different biosimilars already exist in the Indian market, the big money lies launching these drugs in Europe and the United States
It has been more than a decade since Indian pharmaceutical companies began looking at the biosimilar opportunity. It is not an easy space to be in and quite unlike their traditional stronghold of generics. However, it is a space that is linked to the nature of future drugs – today, as is often quoted by pharma experts, one out of every three new drugs approved in the global matkets is a biotech drug, specially in fields like cancer care.
While over 50 (and counting) different biosimilars already exist in the Indian market, the big money lies launching these drugs in Europe and the United States. So far, hardly a couple of Indian companies have been able to do this and much of this happened in the decade that has just concluded. In February 2015, Intas Pharmaceuticals became the first Indian company to get a biosimilar registered – the biotech drug Filgratsim under the brand Accofil – in the European Union. It is now getting ready to foray into US with more products.
“We launched pegylated granulocyte-colony stimulating factor biosimilar in Europe last year. We have three more in the pipeline for Europe and two for the US. Of these, we are hopeful of getting our first biosimilar approved in the US in the next eight months or so,” says Nimish Chudgar, CEO & MD, Intas Pharmaceuticals.
It is however Biocon along with Mylan that emerged during the decade as a company that received an encouraging response, specifically in the US. Biocon is eyeing revenues to the tune of $1 billion from biologics (largely biosimilars) by FY22.
Today, almost all the leading Indian pharma companies have entered the biosimilars space. Apart from Biocon and Intas, players in the segment includes leading names like Dr Reddy’s Laboratories, Zydus Cadila, Reliance Life Sciences, Emcure, Glenmark, Aurobindo, Lupin and Alkem Laboratories.
However, Chudgar feels it is still early days for biosimilars from Indian companies and calls it “an investment for future”. “Those who have invested will reap the benefit in the coming decade. Going by the trend among most countries keen to cut down their insurance bill, we seem to be moving into times when an auto-switch to a biosimilar from an innovator product, like in generics, may happen and this could go a long way in reducing the hassle of promoting these drugs,” he says.
Biosimilars, however, are not the traditional strength of Indian pharma, but generics of synthetic drugs or drugs that are very loosely copies of an innovator drug after its patent has expired. Compared to this, biosimilars are a different ball game – more complex and more expensive as biotech drugs, by their very nature, require understanding of living organisms. Their molecules are much heavier, with complex structures that can change depending on the process used to produce them and the environmental conditions in which they are made. The process employed in making biosimilars affects the taste, even though the end product is the same. Biosimilars comprise complex large molecules – unlike the small molecules of chemical drugs – and proteins or antibodies derived from living sources such as plants, bacteria or mammalian cells. Since these are living sources, their characteristics vary.
Also, this space is more recent from the point of view of the regulatory pathway development. Europe has been well ahead of the US in formulating regulations for biosimilars with the European Medicines Agency introducing the relevant guidelines in 2006. The US passed its Price Competition and Innovation Act in 2010.
So, in terms of challenges and the outlook in this space, Chudgar feels it is early for these products to make substantial impact on revenues. In future, success will depend largely on the selection of the molecule and the speed with which they can be got to the market, he says. “For any of the drugs used in cancer care, the usual time period for clinical trials and clearing the regulatory pathway will take about five years with an investment of around $50 million.”
How companies perform on this count over the next few years will show how we stand on biosimilars and if Indian companies can truly hope to make a dent as they did with small molecules. There are enough sceptics to point out that companies from Korea and China have occupied the biosimilars space, and the best way forward for innovator companies is to do their best to retain their turf even after the expiry of their product patent. This space therefore will need to be watched.
About Taj Pharma
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