Updated on 8 May 2013
By getting the approval process through a variety of approval committees, the process has got thorough but is quite long winding and time to market has significantly got affected in the process.
Thus the process should be stringent while streamlining the committees and hence the review period. Every delay is costing the developers a significant amount of resources and consequently affecting their approval process in other countries either emerging or regulated. Biosimilars are getting highly competitive and time is a key factor to watch out for.
The foreign manufacturers' who wanted to register their product earlier in India had to go directly to the Drug Controller General of India (DCGI) office for approval but after the introduction of new biosimilar guidelines, even their review has come under the purview of Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology (DBT). But despite this, the applicant finds it difficult to figure out who is actually going to review their dossier because of lack of clarity of the roles of the different regulatory bodies among themselves.
The provisions for exporting biosimilar drug substance and drug product have not been addressed in the Indian similar biologics guidelines. Moreover the biosimilars manufactured in India which do not yet not possess a Marketing Authorization; do not face the same scrutiny by the RCGM, DBT with respect to data requirements for CMC, animal and human studies.
Switching and interchangeability of biosimilars have not been addressed in the guidelines along with packaging and labeling of the biosimilars also having ambiguity going forward. The biosimilar candidate, gaining Indian approval may be allowed to use the non-proprietary name of the innovator biotherapeutic reducing the branding of an individual/standalone biotherapeutic with a similar target to the innovator's biotherapeutic, reducing the marketing costs. This again would have to be determined by how similar does the biosimilar candidate have to be to the innovator and the ambiguous "high degree of confidence" mentioned in the guidelines.
As Indian developers gain hands on experience with biotherapeutics, the regulators must give them the adequate support by in depth discussions and making case by case expectations clear. These guidelines are definitely a step in the right direction, but some kinks have to be smoothened out to derive maximum utility for the patients and