Evidently, India makes an indelible mark in the biosimilars space. One of the first countries globally to get approval, marketing biosimilars is one aspect of its acclaimed position. Leaving behind the U.S. by almost a decade, when the first biosimilar for Hepatitis B was signaled in the country in 2000.
The forward-leaning of Indian biosimilars has been perpetual since then. Progressively, till date, there are more than 40 biosimilar drugs available in the Indian market. The pipeline for biosimilars in India is robust, too. According to findings of Transparency Market Research, in 2017, more than 40 biosimilars were in clinical development stage in India – a number equal to the European Economic Area. And far more from the U.S.
This was attained, in part, by subsidies offered by the Indian government for manufacturing biosimilars. A comparatively mature biosimilar manufacturing ecosystem plays role too. So much so, on grounds of its standing, the country can now provide valuable lessons on what it takes to establish a flourishing biosimilar market with respect to accessibility, regulatory strategy, competition, and other aspects.
Nonetheless, in India, the entire gamut of biologic drugs, of which biosimilars are crucial, is set to become an integral part of the future healthcare landscape.
How did Biosimilars expand rapidly in India in recent years?
Apparently unlikely, at present, more than 1000 Indian biopharmaceutical companies are engaged in manufacturing and marketing biosimilars. The shift of these companies from established generic drug manufacturers arose out of competition. Indian pharma companies mostly known as small-molecule generic manufacturers started to intercept competition from global drug manufacturers in the space. Resultantly, downward pressure on drug prices surfaced as repercussions wiping value of Indian pharma stocks nearly 20% between 2016 and 2018.
Facing such adverse headwinds, it became imperative for Indian pharmaceutical manufacturers to create new markets. Fortunately, in such a scenario, plans to expand their footprint in the biosimilars space appeared compelling.
To make a presence, some of the key players in the Indian biopharmaceutical market could raise capital from global lenders to kick off. However, the transformation had its own requirements. Essentially, it required four ingredients: a new mindset and vision, talent acquisition from the biotech industry in developed markets, R&D undertakings, and an inclination to invest in world-class infrastructure, and take risks.
And these were taken with a stride with some top-notch Indian pharma companies. This signaled the foray of some large generic drug manufacturers, including Ranbaxy, Lupin, Alkem Laboratories, and Dr. Reddys in the biosimilar area.
However, not all of them could make a mark for scale and significant share among world’s top companies in the space. Barring a handful, for their long-term vision and willingness to take risk, all of these companies faltered.
What lies ahead for Indian Biosimilars?
In the coming few years, several blockbuster biological drugs are going off patent. According to analysis of an established business intelligence firm, as many as nine drugs among biologics’ patent have either expired in recent years or will by 2025. This creates a huge opportunity for their corresponding biosimilars. In terms of numbers, revenue of these biosimilars is expected to grow 24 percent each year till 2025, finds TMR.
Above this, development of biosimilars is a welcome move from the human standpoint due to their easy affordability as compared to biologics.
Markedly, Indian pharma companies having a presence in this space will benefit the most from this opportunity. Here’s a how;
In the global biosimilars realm, share of Indian companies is nearly one-seventh of the overall revenue by 2030, according to estimates of the Associated Chambers of Commerce (ASSOCHAM) of India. Such revenue share is projected on grounds of active participation of some top Indian companies, including Glenmark Pharmaceuticals, Biocon, and Zydus Wellness in the biosimilars space.
To attain this is, however, is no easy task. This will depend on few factors, including access to critical technology, regulatory guidelines, and price difference between biosimilars and their respective biologics. For instance, the price difference between biologics and biosimilars has widened more than 60 per cent for some drugs in Europe, from 20 per cent few years ago. Explicitly, a wider price difference will enable faster adoption of biosimilars.