Conventional vaccine strategies have been highly efficacious for several decades in reducing mortality and morbidity due to infectious diseases. The bane of conventional vaccines, such as those that include whole organisms or large proteins, appear to be the inclusion of unnecessary antigenic load that, not only contributes little to the protective immune response, but complicates the situation by inducing allergenic and/or reactogenic responses. Peptide vaccines are an attractive alternative strategy that relies on usage of short peptide fragments to engineer the induction of highly targeted immune responses, consequently avoiding allergenic and/or reactogenic sequences. Conversely, peptide vaccines used in isolation are often weakly immunogenic and require particulate carriers for delivery and adjuvanting. In this article, we discuss the specific advantages and considerations in targeted induction of immune responses by peptide vaccines and progresses in the development of such vaccines against various diseases. Additionally, we also discuss the development of particulate carrier strategies and the inherent challenges with regard to safety when combining such technologies with peptide vaccines.

Indian regulatory authorities for biologics, jointly at Department of Biotechnology and Central Drug Standard Control organization in association with the task force comprising Indian biologics manufacturers laid down the regulatory pathway for manufacturing and marketing authorization of similar biologics, claiming to be similar to an already authorized reference biologic. This guidance has come in force from 15 September 2012 in India. This guidance document is a simple abridged process for evaluation of ‘Similar Biologics’ that are approved and marketed either in India, Europe or USA or any other country for more than 4 years.