A good summary, you may agree, but one made in 2007. How do the development and commercialisation of biosimilars stand in India in 2011? Several new reports have recently presented India’s current status and challenges faced.

A snapshot of India’s present biotech industry

India has been a recent entrant into the elite six countries group that have successfully decoded the human genome indigenously, the others being Canada, China, UK, US and South Korea [2].

India’s biopharma segment is witnessing growth. The segment contributed about two-thirds of the value of the total pharmaceuticals sector in terms of value for the year 2010–2011. The vaccine business contributes to over 50% of the biopharma business in India. Indian companies that produce vaccines have been able to master the requirements of good manufacturing practice (GMP) for macromolecules and are continuously earning the goodwill of international companies. India presently has about 15 large vaccine manufacturers that work on over 50 brands for 15 different vaccines.

India is just starting down the biotech road. Today it holds a 2% share in the global biotech market but this low figure hides an industry worth US$4 billion in 2009–2010 that is growing by 52% a year [3, 4]. More optimistic projections for sales revenues of biosimilars in Europe and the US put them as high as US$21 billion over the next six to seven years [5] providing the incentive.

Indian companies have already advanced from making simpler biotech products such as granulocyte colony-stimulating factor to manufacturing more complex biotech products such as monoclonal antibodies [6]. Dr Reddy’s has brought biosimilar version of Roche’s rituximab to market.

Weaknesses and problems

Overall, Indian companies have demonstrated that there is no dearth of technical competence as far as development and manufacturing of biotech products is concerned. But how can they best use the key advantage of an available, qualified, and relatively low-priced workforce? Meeting the international expectations with respect to product quality and GMP compliance will be a large obstacle on the path to manufacturers wanting to emerge as major global players.

The complexity of the biosimilars market is further amplified by industry’s inability to completely characterise biotech products through analytical means. As a result, the biotech process affects the quality of the final product and quality attributes affect clinical safety and efficacy of the product. Being able to manufacture generics is no guarantee of being able to manufacture biosimilars.

Indeed, India still has to establish a reputation for manufacturing active pharmaceutical ingredients (APIs) to international quality standards. For example, the Swiss generic drugmaker, Acino, announced in 2010 that it incurred a loss after EU authorities required a recall of batches of its drug clopidogrel, which had been formulated using an active ingredient from an Indian supplier [7]. 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.

The remainder of the problems can be summarised thus:

• Lack of venture capital. There is presence of abundant private equity, but venture capitalists are still apprehensive about investing in this sector in India.
• Relatively low R & D expenditure by industry. This problem is being addressed.
• Missing link between research and commercialisation. The system of nurturing research in university and taking it to commercialisation is not well rooted.
• Intellectual property is still a worrying perception with companies that work with India.

Steps along the biopharma high road

Much needs to be done for Indian manufacturers to graduate from being considered ‘manufacturers for the developing world’ to the ‘manufacturers for the developed and the developing world’.

Regulatory system. A systematic, science- and risk-based approach for review of regulatory applications and inspections has been put in place. A single point of decision-making and accountability would make the system more efficient, credible, better coordinated and reduce confusion. In addition, basic training in areas such as GMP, documentation practices, scale up, technology transfer and validation is needed by the industry and regulators.

Modern technology platforms to support appropriate decision making during the review and inspection process are needed. Such product quality analyses are already used by some of the major global regulatory agencies, and India could benefit from these technologies.

Standards. The Indian Pharmacopoeia Commission (IPC) is in the process of overhauling its monographs for biotech products. As a creator of the minimum standards that a biotech drug must meet in order to be a commercial product, IPC can play a crucial role in contributing to the success of the Indian biotech industry by using a science-based and risk-based approach when creating these standards.

Academic–industry collaboration. Quality by design (QbD) has gained significant momentum lately in the biotech industry with both regulators and the industry investing financial and staffing resources to implement the approach [8, 9]. A QbD approach is likely to be expected of Indian manufacturers when they apply for FDA or EMA approval of biosimilars. The Indian biotech industry should see this as an opportunity to innovate without compromising product quality and consistency.

Conclusion

India is still at the same crossroads, although a new avenue, biosimilars, is coming into view around the biotech corner. The government, industry, academia and regulators need to work together to clear the path. It remains to be seen whether India will emerge as a dominant global manufacturer of biosimilars.

Related article

Biotech growth and biosimilar opportunities in India

References

1. Frew SE, et al. India’s health biotech sector at a crossroads. Nature Biotechnol. 2007;25:403-17.

2. UK Trade and Investment. Biotechnology and Pharmaceutical Opportunities in India. UK sector briefing September 2011.

3. Chakraborty C, Agoramoorthy G. A special report on India's biotech scenario: advancement in biopharmaceutical and health care sectors. Biotechnol Adv. 2010;28(1):1-6.

4. Chaturvedi S. Global production networks and the Indian biopharmaceutical industry: emerging linkages and prospects. Indian J Labour Econ. 2009;52(2):693-712.

5. Rathore AS. Development and Commercialization of Biosimilars in India. BioPharm International. 2011;24(11):36-40.

6. Jayaraman K. India's Cipla sets sights on Avastin, Herceptin and Enbrel. Nature Biotechnol. 2010;28(9):883-4.

7. EMA. Assessment report for Clopidogrel Acino Pharma. 16 September 2010. EMA/11661/2011 [cited 2011 December 15]. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/001172/WC500104602.pdf

8. Rathore AS, Winkle H. Quality by design for biopharmaceuticals. Nature Biotechnol. 2009;27(1):26-34.

9. Rathore AS. Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol. 2009;27(9):546-53.