India’s guidelines for similar biologics issued by the Government and aimed at providing a clear regulatory pathway for manufacturers of biologic similars, came in for high praise at the Biotechnology Industry Organisation’s (BIO) India international conference.
Prominent personalities said the policies are intended to bring about innovation, collaboration and investment in the biotech sector.
H. Thomas Watkins, ex-CEO of Human Genome Sciences (HGS), said the Indian guidelines bring an end to the era of ad-hoc abbreviated approval pathway, under which Indian authorities have been approving Indian produced generic biologics, with reference products approved in the US and Europe.
Watkins is in the country, his first visit, after relinquishing the top post at HGS, which London pharma major GlaxoSmithKline bought out for $3.6 billion in July 2012.
The 3rd annual BIO India conference, organised by BIO, was in partnership with the Association of Biotechnology Led Enterprises. The new guidelines mandate that manufacturers must prove similarity to a reference product — either an innovator drug licenced in India or approved elsewhere. A four-year post market surveillance on safety data is also part of the guidelines. The motive for India to promote these guidelines is to encourage more domestic and foreign investment in bio-similars in India, with an idea to increase product access and to reduce Government spending on drugs.
Stating that the guidelines were a step in the right direction, Alan Eisenberg, Executive Vice-President, BIO, which represents the US industry, said the guidelines recognised the scientific and regulatory complexities presented by the development and manufacture of biological medicines.
“What should follow next is industry collaboration in the implementation of these guidelines in a manner that continues to protect patient safety and ensure continued research and development of new cures and treatments,” said Eisenberg.