India’s Biosimilars Guidelines Lay Out Best Practices But Marketed Products Not To Be Reviewed – BIO Conference
This article was originally published in PharmAsia News
Executive Summary
The guidelines will enable a standardized biosimilars pathway as opposed to case-by-case application reviews
BOSTON – Almost two years after intensive engagement with the industry and academia, the Indian government unveiled its final regulatory guidelines for biosimilars at the BIO international convention in Boston June 19.
Encapsulated in a 42-page document titled Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, the newly carved out provisions span a host of standards from pre-market regulatory requirements, comparability exercises for quality to post-marketing surveillance systems but will not be applied to the dozens of first-wave biosimilars already on the market.
Balancing Quality And Price
Until now, biosimilars were approved in India by the Review Committee on Genetic Manipulation under the Department of Biotechnology and the Central Drug Standard Control Organization using an abbreviated version of the pathway applicable to new drugs on a case-by-case basis.
Department of Biotechnology Secretary M.K. Bhan emphasized the need to bring in new treatment options in biologics in India, adding that this will be good news for governments and patients alike with significant reduction in costs. Bhan, however, parried questions on the long-pending National Biotechnology Regulatory Authority which, if approved by the Indian Parliament, is to act as a nodal authority to regulate the biotechnology industry, distinct from the Central Drug Standard Control Organization.
Amongst many provisions, the Indian government mandates that a similar biologic can only be developed against an authorized reference biologic approved using a complete data package in India. However, in case the reference biologic is not authorized in India, the guidelines say it should have been licensed and marketed for at least four years with significant safety and efficacy data. “In case of no medicine or only palliative therapy is available or in national healthcare emergency, this period of four years may be reduced or waived,” the document adds.
Avoiding Impurities
For manufacturing, the guidelines require the processes to be highly consistent and robust. “If the host cell line used for the production of the reference biologic is disclosed, it is desired to use the same cell line as the reference biologic. Alternatively, any cell line that is adequately characterized and appropriate for intended use can be used to develop a similar biologic, with appropriate justification in order to minimize the potential for significant changes in critical quality attributes of the product and to avoid introduction of certain types of process related impurities that could impact clinical outcomes and immunogenicity.”
For the establishment and characterization of the cell banks, the guidelines adhere to the technical requirements as laid down by the ICH.
The guidelines also include details on issues like molecular biology such as host cell cultures, gene sequences or post-translational modifications like glycosylation. Essentially, the guidelines seek to closely examine fermentation and downstream process development and product characterization in the submitted comparability dossier.
Biocon Ltd. Chairman Kiran Mazumdar Shaw told PharmAsia News the government has taken a commendable step in setting up the guidelines that can allow low-cost therapies of costly biologics. “Like generics, India should become the epicenter for low-cost biologics and then the emerging markets can help launch products in developed markets,” she said, adding that the products – which are branded by companies - would be substitutable at the pharmacy level.
Indian and global companies have been said to be working closely with the government in framing the biosimilars guidelines (Also see "United We Stand: Regulatory Framework For Biosimilars May Bring Indian And MNCs Closer" - Scrip, 22 Sep, 2010.). Roche however has been critical about the approval standards followed in several of the emerging markets (Also see "Roche Lashes Out At Biosimilars Regulations In Emerging Markets, Calls For Stricter Pharmacovigilance Of Launched Products" - Scrip, 8 Dec, 2010.).
To capitalize on the growing demand for biologics in emerging markets, the Swiss biotech giant joined forces with India’s Emcure Pharmaceuticals Ltd. to manufacture and launch low-cost versions of a suit of biologics (Also see "A Change Of Plans: Roche Teams Up With Emcure For Low-Cost Herceptin, Mabthera In India" - Scrip, 15 Feb, 2012.).