India defines pathway for biosimilars development

At the recently concluded BIO Boston 2012, India reiterated its commitment to providing a conducive policy environment for the development of biotechnology with the release of its guidelines for similar biologics. The policy document broadly speaks about the relevant authorities involved in granting approvals, the clinical trial requirements and also the market authorization of these similar biologics. Find the guidelines issued by the Government of India: India's similar biologics guidelines

Providing a clear pathway for the development of biosimilars for the burgeoning biologics industry in India, the Department of Biotechnology (DBT) defined a biosimilar or similar biologic as "a biological product or drug produced by genetic engineering techniques and claimed to be similar in terms of safety, efficacy and quality to a reference biologic, which has been granted a marketing authorization in India by DCGI on the basis of a complete dossier, and with a history of safe use in India."

So far, similar biologics were approved by Review Committee on Genetic Manipulation (RCGM) and the Central Drug Standard Control Organization (CDSCO) using an abbreviated version of the pathway applicable to new drugs on a case by case basis. The guidelines clearly mark the roles of each of these organizations including that of the Drug Controller General of India (DCGI) for approving the clinical trials and manufacture and market authorization of the biosimilars.

The current guidelines dictate that a similar biologic can only be developed against an authorized reference biologic that has been approved in India. In case the reference biologic is not authorized in India, it should have been licensed and marketed for at least 4 years with significant safety and efficacy data. This requirement can however be waived off if there is no medicine currently or only palliative therapy is available or in case of a national healthcare emergency. Also in case the reference biologic is not marketed in India, the reference biologic should have been licensed and widely marketed for at least 4 years post approval in innovator jurisdiction in a country with well established regulatory framework.

The guidelines also clearly outlines the data requirements to be provided by the applicants for conducting preclinical studies as well as clinical trials for similar biologics. They also state, in detail the requirements for preclinical evaluation of the similar biologic which include pharmacodynamic studies,toxicological studies and the study of immune responses in animls. The applicant should submit the data generated along with the basic clinical information and preclinical study protocols to RCGM for obtaining permission. This is supposed to be accompanied by an approval by the
Institutional Biosafety Committee (IBSC) of the applicant and an Institutional Animal Ethics Committee (IAEC), if available

Other features of this policy document include the data requirements for market authorization application and post-market data. For cases where commercial manufacturing is performed either at a different scale and with a different process as compared to that used for manufacturing phase III clinical trial batches, the information on comparability of quality needs to be additionally submitted The implementation of this rule is also noteworthy considering the low rates of companies submitting post marketing surveillance data, as evidenced in the recent 59th Parliamentary report on the CDSCO.