Development and Commercialization of Biosimilars in India - The author aims to present the current status of India in this context, the challenges that need to be overcome, and some recommendations th

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Development and Commercialization of Biosimilars in India
The author aims to present the current status of India in this context, the challenges that need to be overcome, and some recommendations that may alleviate these challenges.


BioPharm International
Volume 24, Issue 11, pp. 36-40

MANUFACTURERS AND CLINICAL RESEARCH ORGANIZATIONS




More than 30 biopharmaceutical companies and clinical research organizations are based in India (see sidebars on companies and contract organizations) (4, 5). The biopharmaceutial sector's estimated value was $1.9 billion in 2009–2010, and accounted for three-fifths of the approximately $3-billion in revenues of the biotech industry in India as a whole. More optimistic projections for sales revenues of biosimilars entering the US and Europe have been estimated as high as $21 billion for the next six to seven years. India is also emerging as a hub for conducting global clinical trials with its share going from 2% at present to 5% by 2012, based on low cost, large and diversified patient pools, easy recruitment, strong government support, availability of specialized doctors and trained investigators, and a gradual strengthening of the IP environment (5, 6).

The clinical research organization market has increased from $5 million in 2005 to $71 million in 2006, and reached $1 billion in 2010 with 50,000 clinical research professionals and 400 clinical trials involving 100,000 patients at 300 sites (7).


Table I: Major biosimilars being manufactured in India and their manufacturers (Data, Ref. 8).
Indian companies have gradually advanced from making simpler biotech products, such as the granulocyte colony stimulating factor to manufacturing more complex biotech products, such as monoclonal antibodies (see Table I) (8). Dr. Reddy's has brought biosimilar version of Roche's Rituximab to market.

Overall, Indian companies have demonstrated that there is no dearth of technical competence as far as development and manufacturing of biotech products is concerned.

COMPETITION AND GLOBAL EXPECTATIONS


Figure 2: Countries that US firms are considering as potential outsourcing destinations. (Data, Ref. 9).
A recent survey focused on countries that US firms are considering for outsourcing (see Figure 2). Results showed that Singapore, Ireland and India are the top choices, followed closely by China and Germany. The competition for leadership in development and commercialization will be intense among the more established players (i.e., Germany, Singapore, and Ireland) as well as the emerging ones (i.e., India and China).

The developed countries (i.e., US, Europe, Japan) have a long history of manufacturing biotech products for regulated markets, but the developing countries have the key advantage of an availabile, qualified, and relatively low-priced workforce. However, more is needed for the latter group to completely embrace the principles and expectations with respect to product quality and GMP compliance, and this will be a large obstacle on the path to these manufacturers emerging as major global players.

The complexity of the biosimilars market is further amplified by industry's inability to completely characterize biotech products through analytical means. As a result, there is limited understanding of how the biotech process affects the quality of the final product and how quality attributes affect clinical safety and efficacy of the product (10, 11).

In the current environment, any missteps by an Indian manufacturer may to result in a perception that the biosimilars manufactured in India (or any other developing country) are not of adequate quality. For example, the Swiss generic-drug maker, Acino, announced that it incurred a loss after European Union authorities required a recall of batches of its drug Clopidogrel, which had been formulated using an active ingredient from an Indian supplier (12). The European regulators ordered the recall after an inspection of the Indian firm led to the finding that it had compromised production records for Clopidogrel.


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