Biosimilars or biosimilar durgs are biological medical products which are identical copies of an original product that is manufactured by a different company. They are officially approved versions of original products that are manufactured when the original product’s patent ends.
In 2012, the Indian government had launched the country’s biosimilar guidelines and is now ready to release the much awaited revised version of the guidelines for approval of biosimilar drugs in the first week of July. This move is expected to bring clarity to the launch of such drugs in the country.
The governments’ Department of Biotechnology is looking forward to unveil biosimilar drugs for diseases such as cancer, diabetes and rheumatoid arthritis, to serve twin purposes of providing affordable drugs to patients and making Indian biotech industry globally competitive.
“With manufacturing of indigenous drugs, an ecosystem will be created for innovative indigenous product development by researchers, startups and SMEs to make Indian biotech industry globally competitive. India which today occupies only 3% of the global market aims to reach 5% by 2022,” said Renu Swarup, senior adviser and scientist, department of biotechnology, ministry of science and technology. “In India, there is a large pool of patients that consumes these drugs. With biosimilars, the indigenous drugs will be available at a much less price which will in turn benefit patients in the long run,”
she added, pointing to the market shift to diseases like cardiac conditions, diabetes and cancer which have treatment options with complex biotech drugs resulting in the rise in number and quality of tertiary care centres that in turn has led to greater usage of biotech products.This move comes amid questions from global drug makers like Swiss biotech giant Roche, which dragged the government to court over the process followed for approvals of a few such drugs. The Swiss drug maker had recently sued the Drugs Controller General of India (DCGI) to block approvals for Hyderabad-based Hetero Drugs’ ‘biosimilar’ of its blockbuster cancer drug, Avastin (bevacizumab).
Meanwhile, biosimilars in the country presently include insulin, erthropoietin, chorionic gonadotropin, streptokinase, interferon and heparin; and the market is growing fast with only 14 biosimilar drugs available in 50 brands in 2005 and the number increased to 20 such drugs in 250 brands in 2011.
