Newspaper: The Financial Express
Section: Reflect
Date: 8th Nov, 2010
Page: 9

How to ride the biosimilar wave


India's biosimilars market has considerable commercial potential. It is expected to reach around $580 million by 2012

While India's biopharma industry is growing and has the potential to deliver the next blockbuster drug with appropriate techno-scientific entrepreneurship inputs, there is still no formal regulatory framework for biosimilars in the country . The Vision 2020 Biopharma Strategy , jointly prepared and released recently by the Department of Pharmaceuticals, the Association of Biotechnology Led Enterprises (ABLE) and PwC, has detailed the measures for the industry and the government to work towards making India 1 of the 5 toppers in the sector and grabbing 10% of the $319 billion global market by 2020. The document emphasises that the government has to play a major role in creating an appropriate ecosystem by building human capital, simplifying and modifying the regulatory framework, and investing $1 billion over the next 10 years to achieve the goal.

Biopharmaceuticals are medical drugs typically derived from living systems and produced using biotechnology .
Biosimilars are similar, but not identical, to already registered biological medicinal products in terms of quality , safety and efficacy. Unlike the more common "smallmolecule" drugs, biosimilars generally exhibit high molecular complexity , and may be quite sensitive to manufacturing process changes. The biosimilar manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process. India's biosimilars market is at a nascent stage but has considerable commercial potential. It is expected to reach around $580 million by 2012 and about 50 Indian biosimilars have already reached the country's markets. But India does not have a regulatory framework that addresses a full complement of data, including clinical evidence, to demonstrate the safety and effectiveness biosimilar products, although regulatory authorities has frequently acknowledged that biotechnology products can be difficult to characterise. Biosimilars are not easily shown to be equivalent to innovator products. Therefore, criteria for regulatory approval have to be different from those for traditional generics. Comparability studies are needed to substantiate the similarity of the quality , safety and efficacy of the biosimilar and the innovator products.

Hence the necessity of regulatory measures addressing relevant nonclinical and clinical data. Post-marketing surveillance and risk management plans should also be in place for the approval of biosimilar products.
Industry and stakeholders recommend a single-window clearance mechanism for commercialisation of biosimilars. In most countries, a single central body is responsible for everything from reviewing non-clinical data to granting permission for clinical trials. In India, by contrast, the review process extends across multiple bodies like the Drug Controller General of India, the Indian Council of Medical Research, the environment and forests ministry and the Department of Biotechnology .

The regulatory framework, of course, should remain to be based on science. As India is aiming to position itself as a global leader in biosimilars, capitalising on a growing global demand and making infrastructure investments accordingly , it will have to maintain harmony with the standards laid down by the European Medicines Agency Evaluation of Medicines for Human Use (EMEA).

Otherwise, Indian biosimilar products will not be recognised and accepted in the highly regulated western markets. After all, the hallmarks of internationally reputed biopharma brands are stringent standards for controlling quality , safety and efficacy .

The author is partner, Corporate Law Group