India is leading the global biosimilar channel with the largest number of products being launched in the country. Reliance Life Sciences tops the list, followed by Intas and Biocon. Biosimilars are approved versions of biopharmaceuticals, which are complex medicines manufactured using living organisms, in contrast to conventional drugs that are based on chemical composition.
At present, domestic companies are marketing their products only in emerging markets, but they are soon to move towards large lucrative pharmaceutical markets. Thus, Indian pharma companies are moving up the value chain, while slashing down treatment costs by 20-40% for chronic and life-threatening illnesses like cancer and rheumatoid arthritis. Domestic companies are leading the chart with three proposed launches – etanercept, tenecteplase and human growth hormone. These three medications are used to treat rheumatoid arthritis, myocardial infarction, and growth hormone deficiency respectively.
Reliance Life Sciences is to strengthen its position with 18 biosimilars in the next few months. The company’s CEO and company president, KVS Subramaniam says, “Reliance Life Sciences has pursued a strategy of developing, in an integrated manner, a wide array of biosimilars at competitive prices to meet patient needs on a global basis. Being recognized as the top biosimilar player globally, in terms of number of products, is one testimony of this strategy in practice.”
However, there are many challenges one has to face in the field of biosimilars, in terms of extensive product characterization, clinical trials, high costs of development, establishing interchangeability with innovator drugs, and dealing with longer development and regulatory pathways. But, in spite of all this, biosimilars have helped bring down prices for patients. For example, the net prices for innovators have come down 14% for a 500 gm rituximab, 18% for a 100 gm bevacizumb, and 45% for a 30 mg pre-filled syringe of interferon beta. Moreover, Indian companies are exporting biosimilars to other countries like Africa, Latin America, South Asia, and Southeast Asia, meaning more profits!
Now let us speak of the domestic Ahmedabad-based Intas Pharma, who has developed 13 indigenous products in the domestic market, and has launched its second biosimilar pegfigrastim (Brand name Pelgraz) in the European market, after its first biosimilar filgrastim (Brand name Accofil). This is the only company with two biosimilars ready to be filed for registration in the US. Accofil is the company’s highest revenue-generating biosimilar with 15% market share in the European Union. The Managing Director and Vice Chairman of Intas, Binish Chudgar said, “The estimate of the global biosimilar market is $9.5-13 billion by 2022, despite the fact that over $90 billion worth of biotech-based medicines are expected to go off-patent in the next few years. Much of the activity in biosimilars is taking place in Europe, while the US, which is the largest pharmaceutical market in the world by a wide margin, has not really opened up to these products. On the domestic front, with a very supportive regulatory authority, biotechnological medicines are set to become an important part of future healthcare landscape.”
These are only two examples of Indian pharmaceutical companies going global with its biosimilar successes. There are many others on the list. But, have you imagined the reason behind this success? It is the fruitful efforts of the dedicated clinical research professionals in our country who have been putting in their time and hard work to create these magics! You could also be one of them in the future bringing up the name of our country even brighter if you have the passion, and education from one of the top clinical research institutes in Bangalore; one like Avigna Clinical Research Institute. Here, you can learn online right from the comfort of your home, the courses led by professionals, and achieve a valid and legitimate clinical research diploma certificate that can help you get the best jobs in the country!
