On 28 March, Biocon Ltd said it has got regulatory approval to launch the biosimilar version of insulin glargine in Japan. The 14.2% rise in Biocon’s share price since then is partially owing to this approval and also to a re-rating of the stock by Morgan Stanley. A biosimilar is a drug that is similar to the original biological product.
The market for biosimilars is an attractive one for Indian companies, with Japan being the third-largest market after the US and the European Union (EU), according to a recent report by IMS Institute for Healthcare Informatics. The current market size of the top eight biologics losing their patent protection between 2015 and 2020 is shown in the chart.
That is a sizeable market opportunity opening up. The US is the largest, with an estimated market size of €199 billion between 2016 and 2020, while the EU5 countries (Germany, France, Italy, Spain and the UK) will contribute €47 billion. On 5 April, the US Food and Drug Administration gave its second biosimilar approval, for infliximab; earlier on 6 March, it had given an approval for a biosimilar of filgrastim.
Indian firms are using differing strategies, some doing the research themselves while others are attempting to lower risk by taking the licensing route. Either way, getting a successful biosimilar into a developed world market will be a feather in the cap for any Indian company. They are still some time away from a successful launch and this opportunity is not without risks, such as delays in regulatory approvals, more competition than anticipated from other biosimilars or government-mandated price cuts such as what has recently happened in Japan.