Hailing the step, Mr Lee adds, "The introduction of the guidelines is a significant step forward in progressing the interests of the biosimilars industry in the country. By defining a framework for biosimilars development that is not too dissimilar from the European Union and World Health Organization (WHO) guidelines and the draft US guidelines, the Government of India is very clear in its intent to create a level playing field for the development of biosimilars and elevate the domestic industry to a global level."

Welcoming the government's initiative, Mr K V Subramaniam, president and CEO, Reliance Life Sciences, who was part of the drafting committee, says, "The Indian Biosimilars Guidelines are comprehensive in nature and address the pre-market and post-market regulatory requirements for biosimilars. The document clearly delineates the roles and responsibilities of authorities in the approval process. The RCGM oversees product quality, characterization, approval of protocols and review of preclinical toxicology studies, while the DCGI focuses on the approval and review of clinical trials and marketing authorization."

He adds that the guidelines state that all biosimilars should be compared to the reference or innovator product through all phases of development. "There is clarity on the quality and quantity of data expected, for example, the number of batches, bioassays and analysis of products for post translational modifications. Animal studies have also been rationalized by allowing short-term studies in relevant animal species. When such models are not available, it is recommended to follow Schedule Y of the Drugs and Cosmetics Act. Some redundant studies have been eliminated reflecting the current scientific understanding," he says, elaborating on the guidelines.

Dr Krishna Ella, chairman and managing director of Bharat Biotech International, a leading bio-similars company from India, terms it as a welcome step in the right direction. "Guidelines will streamline the approval process and bring clarity to all biosimilars manufacturers. The new guidelines clarify several issues relating to product development and licensure," he says.

According to Dr Ella, such guidance documents on several aspects of the regulatory process in India would be welcomed by industry. "Guidelines laid out for clinical evaluation, pre clinical evaluation, manufacturing process validations, product characterization, etc. are welcome and these guidelines should be enforced strictly across the industry. We are happy that with the introduction of this policy, there is going to be an adherence of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines (Q5A,Q5B, Q5D)," he says.