Updated on 8 May 2013
The Central Drugs Standard Control Organization and Department of Biotechnology mutually formed and implemented the national regulatory guidelines on 'Similar Biologics: Requirements for Marketing Authorization in India' from September 15, 2012 onwards. These guidelines were much needed as many of the highly expensive innovator biotherapeutics came close to their patent expiry and Indian biopharmaceuticals manufacturers needed clear regulatory process for the development of biosimilars in India.
The guidelines were created with the rationale of creating access to affordable drugs at reasonable prices while maintaining the quality and thus safety and the efficacy. In markets like India, only a sliver of the population could perhaps pay for the biotherapeutics at the innovator's exorbitant prices. The guidelines want Indian innovation to complement the low cost manufacturing capabilities possible in India and thus attract international investors.
Indian guidelines have been based on the European Medicines Agency (EMA) guidelines and this has raised the bar for approval process for our country. Indian developers understand that the regulators want to give them a shot at clearing the standards of the regulated countries and realize the significant export opportunity in these markets helped by India's low manufacturing capabilities. This will help us overcome the myth of "Made in India" biologics-unlike the Indian generic counterparts where such stringency in regulatory pathway is not required to make a name and there is consequent widespread acceptance.
More than 20 biosimilars have been approved in India through a standalone approach before the Indian similar biologics guidelines were released. These "biosimilars" are yet to gain an approval from the regulatory markets like European Union, Australia, Canada, US and Japan. This raises a question on the lack of comparability process required for the approval of these biosimilars at that time.
The new generation of Indian similar biologics guidelines being developed on the basis of the stringent comparability requirements of similar biologics would have to overcome a "Made in India" bias with respect to quality and approvability for the regulated markets. This has been a factor for Indian biosimilar developers looking to collaborate with international players.
While keeping the foreign export potential in mind with high quality biosimilars, the developer must have some incentive to develop biosimilars. This cost of development goes up as head-to-head comparability studies with the innovator's product are required starting from the first-Chemistry, Manufacturing and Control (CMC) section. Thus a balancing act is required to maintain low development cost to make the final biosimilar retain its quality, safety and efficacy.