Biological drugs having a market worth USD 50 billion will lose patent protection in USA alone, creating a huge opportunity for pharmaceutical companies to come out with biosimilars, according to a report by Grant Thornton.
Biosimilars can be a "copy of" or "similar to" the biological drug whose patent has expired, but not identical to the biological drug. Unlike chemical-based generic small molecule drugs, biosimilars are large complex drugs.
"It is estimated that between 2009 and 2019, 21 biologics with a market value of over USD 50 billion will lose patent protection in the US alone."
"The global market for biosimilars is estimated to grow to USD 3.7 billion by 2015 with the impending patent cliff being the key driver for development and collaboration activities across the globe," the report said.
The report 'Bio-dynamism-Insights into the Biosimilars market: An overall perspective' was released yesterday by Minister of State for Commerce and Industry D Purandeswari during the conclusion of BioAsia 2013.
One of the key drivers promoting the development of biosimilars is that they are an affordable alternative to originator medicines (by around 20-25 per cent). This is largely due to reduced number of clinical trials which in turn result in increased patient access and affordability of treatment, the report said.
However, the industry is facing problems with respect to regulatory issues, it said.