It has been over a decade since Indian 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 the future drugs -- today, as is often quoted by pharma experts, one in every three new drugs approved in the global markets is a biotech drug, especially in fields like cancer care.
While in the Indian market, there are estimated over 50 (and counting) different biosimilars already, the big money lies in being able to launch these drugs in markets of Europe and the US. So far, hardly a couple of Indian companies have been able to do this. Much of this happened in the decade just concluded.
Intas Pharmaceuticals became the first Indian company to get a biosimilar registered of the biotech drug Filgratsim under the brand Accofil in the EU in February 2015. It is now getting ready for more products and for foray into the US.
Nimish Chudgar, CEO & MD, Intas Pharmaceuticals, speaking to Business Today, said: "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."
It is, however, Biocon, along with Mylan, that during the decade emerged as a company that launched products in these markets, and even received a good response in the US. Biocon is looking forward to $1 billion biologics (largely biosimilars) revenue by FY2022.
Today, almost all the leading Indian pharma companies are into biosimilars space, with all having a biotech branch on their pharma tree. Other than Biocon and Intas, the big names include 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 when it comes to Indian companies. He calls it "an investment for future". "Those who have invested will reap the benefit in the coming decade," he says. But he feels "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". This, he says, could go a long way in reducing the hassle of promoting these drugs.
This space is, however, not the traditional strength of the Indian pharma, which is generics of synthetic drugs or drugs -- very loosely, copies of an innovator drug after its patent expires.
Compared to this, biosimilars are a different ball game -- more complex and more expensive, essentially because 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.
Just as in the making of curd, the process employed affects the taste, even though the end-product is the same. Also these comprise complex large molecules -- unlike small molecules of chemical drugs -- and are 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 what are the challenges and how's the outlook in this space? Chudgar feels it's too early to say that these products are making any material impact, including in terms of revenues. But in future, their success will depend on the selection of molecule and the speed with which they enter the market. Because, as he says, "It only makes sense if for one among the top three biosimilars in any market -- and for any of the drugs used in cancer care -- the usual time period for clinical trials and clearing the regulatory pathway takes about five years, with an investment of around $ 50 million."
How companies perform on this count over the next few years will show where India stands on biosimilars. There are already enough skeptics to point that companies in Korea and China have taken the lead in this space, and how companies are doing their best to retain their turf even after expiry of their product patent. This space will, therefore, need to be watched.