Biosimilars will replace some 70% of global chemical drugs over the next couple of decades, according to industry experts. This replacement will occur due to the better safety profiles of biosimilars compared to chemical drugs and the fact that many originator biologicals will lose their patent protection in the coming years, according to Mr Appaji, Director General of Pharmaceuticals Export Promotion Council of India (Pharmexcil).
Mr Appaji expects at least US$80 billion worth of originator biologicals to go off patent by 2015 in the US alone, enabling the biosimilars market to reach US$10 billion in 2015 from its current US$500 million.
China and South Korea currently dominate the copy biologicals market, with India coming in as a distant third, with a share of about 3%. However, Mr Appaji expects the Indian share to increase to 20–25% over the next five years. The main reason for this prediction is the fact that more than 100 major Indian pharmaceutical companies are investing in research in ‘similar biologics’. Seven of these Indian companies, Avesthagen, Biocon, Cipla, Dr Reddy’s Laboratories, Intas, Reliance Life Sciences and Wockhardt, already have ‘similar biologics’, as the Indian regulatory authorities call these products, on the market in India.
Similar biologics have been on the market in India for some years already and India has by far shown the greatest acceptance of such products. However, regulatory guidelines for similar biologics were only implemented in September 2012. Prior to this similar biologics were approved in India following the generics pathway, but with more data being required.
Editor’s comment
It should be noted that similar biologics approved in India may not have been authorized following as strict a regulatory process as is required for biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
China, one of the largest pharmaceutical markets in the world, has yet to issue biosimilars guidelines. Despite the lack of a separate pathway, domestic copy biologicals have been on the market in China for 20 years. Copy biologicals in China therefore have to go through a new drug or generic drug approval process.
South Korea introduced guidelines for biosimilars, based on the European, Japanese and World Health Organization guidelines, in 2010.
Source: www.gabionline.net
