The floodgates have opened for the first wave of the monoclonal antibody (mAb) biosimilars in the two most rewarding pharmaceutical markets US and EU. As several big pharmaceutical companies are gearing up for the opportunity, the Indian companies are conspicuous by their absence. Despite 15-year history of biosimilar development and commercialization, Indian companies are nowhere in the race for biosimilars in either US or EU. So far, only Intas Pharmaceutical, of Indian origins, has launched Accofil®, a filgrastim biosimilar, in Europe .
The age of biosimilars in India began at the dawn of the new millennium when Biovac-B® was launched by Wockhardt in 2000 . Since then, the domestic market has been flooded with biosimilar launches. World’s first rituximab biosimilar (Reditux® by DRL ), adalimumab biosimilar (Exemptia® by Zydus Cadila ), and trastuzumab biosimilar (CanMab® by Biocon ) were all developed and launched in India.
The biosimilar launches in India have been commercially rewarding, the domestic market is expected to increase from $250 million in 2015 to $40 billion in 2030 as per the estimates from Asocham – Sathguru report . As per KPMG, Indian domestic market will grow to $1.1 billion by 2020 .
Biosimilars provide the much-needed cost benefits and patient access to life saving drugs in the price sensitive Indian healthcare market. Currently, over 50 biologics have been approved in India of which 50% are biosimilars.
Figure 1: Key biosimilar developers & products in India 
It is evident that much of Indian Companies´ biosimilars competitiveness is restricted to India and neighboring markets. In 2012, when biosimilar regulatory guidelines were published, several Indian pharmaceutical companies showcased their intent to compete in the US/EU markets, fully confident in their ability to repeat their success in the small molecule generics. Almost 5 years since, no Indian Pharmaceutical company seems close to the biosimilar space in the lucrative western markets. At present, Biocon is the only company which is in position to leverage its partnership with Mylan and compete in the US and EU biosimilar space .
Biosimilar business requires a different set of skills when compared with the small molecule generics. While the overall bench-to-market value chain is essentially similar in both types of generics, the devil resides in the details such as analytical characterization, non-inferior clinical evidence, (semi-) branded commercialization, etc. The fact that Indian developers are marketing products locally, manufacturing and clinical development do not seem like challenges. However, the inexperience or lack of expertise comes to the fore, in the extended clinical development as per the stringent US/EU guidelines and a semi branded marketing approach needed across multiple stakeholders across the healthcare value chain.
A typical biosimilar development program takes about 7-8 years and costs approximately USD 100 – 250 million as opposed to USD 1-4 million for a small molecule generic that can be developed in 1-2 years for US/EU markets . Such high development costs coupled with long investment timelines (thereby creating an unfamiliar risk) and the need for a semi branded commercial model, create additional entry barriers for Indian developers.
Is it strategy or incapability that marks the absence of Indian companies in the US and EU markets? Are the high entry barriers for the biosimilar industry in the US/EU markets, keeping Indian players at bay? Are Indian developers cautiously waiting for the biosimilars to morph into biogenerics? We will explore the answers to these questions in the next part of this two-part series.