India’s biosimilars market stays buoyant

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.

Nonetheless, the regulatory framework for the entire pharmaceutical sector in India is favorable, too. This is strengthened by the fact that India is one of the leading contributors for generic drugs worldwide alongside China. Akin to generics, presumptions pertaining to production of biosimilars in the country are rife.

So much so, India currently leads the biosimilars pipeline globally. Besides this, earlier, India ranked top for the number of biosimilar products among emerging economies. Reliance Life Sciences followed by Intas and Biocon, among Indian pharma majors, are in that pecking order of position in the global biosimilars space.

Nonetheless, domestic companies are on the top in terms of revenue share in the biosimilars market in India. This holds bright in the coming years too. Reliance Life Sciences has proposed three launches, namely etanercept, tenecteplase, and human growth hormone in the near-term. This, along with launch of 18 biosimilars over the next few months will consolidate Reliance Life Science’s position for its offerings.

Meanwhile, some of the top-rated domestic players have made mark for global presence too. A leading Indian pharma company recently launched its second biosimilar drug pegfigrastim in the highly checked European market. The company holds further sway. This is the only company to be ready with two biosimilars to be filed in the U.S. for registration.

Earlier, the presence of this company in some other emerging markets has gained grounds. Some of its biosimilar products such as filgrastim and pegfilgrastim are being marketed under various brand names in these markets.

Conversely, partnering with Indian pharmaceutical companies benefits pharma companies based in major markets. Partnership of Canadian pharma major Apotex with Intas is a case in point. On account of the partnership, Apotex earned access to Intas’ biosimilar drugs, which have been developed cost-effectively. In turn, Intas received capability to commercialize its products in Western market. Hence, win-win for both companies.

Pharma Industry Events – a Platform for Business Associations

The road ahead for these companies is significantly challenging though. Biosimilars pose challenges with respect to clinical trials, extensive product characterization, establishing interchangeability with innovator drugs, subject to longer development and regulatory pathway, and high cost of development.

Partnerships and associations between companies can play a key role to make expansion of biosimilars viable on a commercial scale. Firstly, likewise biologics, biosimilars require a large investment outlay for two reasons: high cost of product development and regulatory compliances and, significant amount of time to bring a product to market.

Pharmaceutical and bio-pharma events such as CPhl and P – MEC India are mega platforms that unite more than 100,000 pharmaceutical professionals each year for business opportunities in the pharma sector. Such events provide a platform to bring together Indian biosimilars manufacturers and multinational pharma giants for alliances and collaborations for R&D and drug manufacturing.

The outreach of Indian biosimilar companies at present is limited. These players are currently marketing their products only in emerging markets – but the next stop is US – the largest and most profitable market for pharmaceuticals. However, much of the activity for biosimilars at present is taking place in Europe. Interestingly, the U.S., which is the world’s largest pharmaceutical market by a large margin has not opened up to most of these biosimilar drugs.

Such targets indicate the growing competitiveness of India pharma companies. A signal of strengthening the position of these companies in the value chain of the competitive spectrum, which was only known for the manufacture of copycat drugs for decades. Above this, with this competitiveness, treatment costs of several chronic and life-threatening diseases such as rheumatoid arthritis and cancer have declined by 20-40%.

About Author: Shveta Garg is a writer with Transparency Market Research, a market intelligence company based in the U.S. Having lived and worked in various countries of the world the USA, the UK, France, and India, she has rich experience of cultures and traditions of the regions of the world. Shveta mainly writes in areas of science and technology, consumer goods, and energy. She has a keen interest in exploring trends, innovative products that will steer the course of these business areas in the future.

*The views expressed by the author are her own.