India has announced the revised guidelines on similar biologics to address the regulatory requirements for marketing authorisation of biologics in India. The guidelines specify the regulatory pathway regarding manufacturing process and safety, efficacy, and quality aspects for similar biologics, besides addressing the pre-market regulatory requirements including comparability exercise for quality, preclinical, and clinical studies and post market regulatory requirements for Similar Biologics, says Narayanan Suresh, Chief Operating Officer, ABLE
The Narendra Modi government has announced another major initiative to help the biotech industry by formulating the revised guidelines for biosimilars that has become effective from August 15, 2016. The new biosimilars policy, called the “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT), has been notified by DBT on August 18, 2016.
The Guidelines were prepared jointly by the members of a taskforce set up by CDSCO and sub-committee of the Review Committee on Genetic Manipulation (RCGM). The guidelines of 2012 were revised through a consultative process with various stakeholders led by members of ABLE (Association of Biotechnology Led Enterprises), other industry associations, leading scientific institutions and labs and through the public review process.
“Although case-by-case examination is important, these guidelines provide the required clarity and essentiality of data requirements for providing the similarity, physico-chemical characterisation, preclinical structures and clinical trials,” said Dr K VijayRaghavan, Secretary, Department of Biotechnology (DBT), Government of India.
How will the guidelines help the biotech industry?
“I expect to see a surge in Indian companies developing Biosimilars. This will lead to a large global opportunity along the lines of generic drugs where India can attain leadership,” said an optimistic Dr Kiran Mazumdar Shaw, Honorary Chairperson of ABLE and CMD, Biocon. She has been a key member of the CDSCO task force that deliberated for over a year and finalised the guidelines at a meeting in New Delhi on August 6, 2016.
According to a Special Report on Biosimilars prepared by Invest India, under the Department of Industrial Promotion and Policy (DIPP), the global market for biological drugs will touch the $290 billion mark in 2020 and account for 27 per cent of the pharma sales. In that the biosimilars will be a $25-35 billion opportunity by 2020.
Currently, 450 biosimilars have been approved globally and another 250 are in the pipeline.
Added Dr GN Singh, the Drug Controller General of India (DCGI), “These revised guidelines will go a long way in providing guidance and documentation support to both applicants and regulators for the development, approval and post-marketing evaluation of safety and efficacy of similar biologics in the country and provide access to affordable biotherapeutics to the patients across the globe.” The guidelines provide the regulatory pathway for a Similar Biologic claiming to be Similar to an already authorised Reference Biologic. These guidelines are for the guidance of all stakeholders and are not meant to substitute or rephrase the Rules made under Drugs and Cosmetics Act, 1940 or any other relevant Acts and are subject to being in conformity with the Drugs and Cosmetics Act and Rules as may be amended from time to time.
To know about some of the key changes that have been incorporated in the revised biosimilars guidelines, read http://www.ableindia.in/frontend/briefnews/68
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