A biosimilar is a biological medicine which is very similar to another already approved biological medicine. The EU and the USA have over 18 years of experience using biosimilars as well as follow-on products which are copies of biological drugs which are yet to be approved as biosimilars.
Recently, more and more follow-on products are being approved across the world. In fact, there are over 300 unique follow-on biologics from a range of manufacturers for the eighteen active substances which are included in the study discussed below.
Out of these 300 unique biologics, over 20% have been approved as biosimilars in the big biosimilar markets of the EU, US, Canada, Australia and Japan. The remaining 80% have not been approved in 1 or more of these countries.
Biosimilars such as the likes of epoetin alfa, human insulin, filgrastim, and somatropin are older biologics which were approved before 2010. Out of the 300 unique biologics, most of them are manufactured in India, China and Russia. With some also coming from Iran and Argentina.
Unfortunately, only 7 follow-on biologics which come from India have been approved as biosimilars in the EU, US, Canada, Australia and Japan. The same goes for one from China.
An Indian-based drug manufacturer, known as Reliance Life Sciences, has managed to produce the highest number of follow-on biologics. They have managed this for twelve of the active eighteen substances. However, these follow-on products are not approved as biosimilars in the EU, US, Canada, Australia and Japan.
Regardless, two other Indian companies, known as Intas and Biocon have managed to produce follow-on products which have been accepted as biosimilars in at least one of the 5 biggest biosimilar markets of the EU, US, Canada, Australia, and Japan.
In addition, the Russian-based manufacturer Biocad and Iranian-based manufacturer Cinnagen are the largest producers of follow-on biologics for the 18 active substances outside of India. Despite this, none of their products are available as biosimilars in the bigger biosimilar markets of the EU, US, Canada, Australia and Japan.
Some organisations treat biosimilars as chemical drugs which don’t need extensive testing against the original product, such as insulin for example. This is why they are used in some countries but rejected by others, who do require extensive testing before the product goes on the market.
What is the future of the biosimilar market?
By 2026, the global biosimilars market is expected to reach nearly 45 billion USD. Biosimilars offer patients more affordable medicines. They make these treatments more accessible and improve the quality of life for patients. Biosimilars are expected to help lower the healthcare system's costs and improve healthcare overall.
