India’s pharmaceutical industry caters to about 30% of the world’s generic requirements. Despite its tremendous volume, it has been facing difficult times recently, with the WHO stance on counterfeit drugs, as well as seizure of Indian generic shipments in the EU.

There is some good news now on the turf with the introduction of Bipartisan Biogenerics Consensus Bill: Promoting Innovation and Access to Life-Saving Medicine Act in US which shall open up the US markets to biogenerics. It is proposed by Rep. Henry A. Waxman who is also credited with an existing legislation on pharma generics to his name. (Hatch-Waxman Act) The Bill intends to authorize FDA to approve generic biotech drugs and provide a regulatory set up for the same. This would help Indian companies to launch their biological generics in US by 2010.

The patent protection for blockbuster first-generation biotherapeutics developed in the West has begun to expire, throwing them open for generic exploitation. While continued high demand, high prices, and applicability in previously untreatable conditions are behind the success of branded biologics, the absence of generic competition has meant that the growth has gone unchallenged.

The US Approach

While recognizing patient need for affordable drugs and the constant need to foster pharmaceutical innovation, the US authorities are keen to develop framework on timely resolution of patent disputes and market exclusivity provisions consistent with the Hatch-Waxman model. The highlight of the Bill remains the reduction in the exclusivity period to 5 years, with a possibility of extension to 3 more years in certain cases, which is 7-10 years at present. Global Pharmaceutical Association (GPhA), that represents the manufacturers and distributors of generic and active pharmaceuticals, says on its website:

“As our nation acts to strengthen our health care system, our priority must be to reduce costs while increasing access to quality care.”

For firms looking to develop biosimilars, some 75 proteins and peptide therapeutics were recently identified in US as potential profitable targets for new products. And significantly, a substantial proportion of these were approved as NDAs, meaning thereby that they can be targeted by biosimilar firms.

Indian and Chinese Markets

The Indian and the Chinese drug regulatory systems have since long favoured domestic generic companies through less rigorous regulations for pharma approvals and clinical testing standards. Currently, insulin, interferon alpha, erythropoietin (EPO), monoclonal antibody (MAb) products and recombinant vaccines are the biosimilars manufactured by a number of domestic biotech companies including Biocon and Wockhardt, who are keen to sell them in US. Biocon’s Insulin is slated to be the first biogeneric to hit US markets in 2011. The Indian government has also streamlined some of its drug application and review procedures in order to cash in on the opportunities.

The biotech industry has been investing heavily in the development of facilities as a result of strong tax incentives. The Indian biogeneric manufacturers are also upbeat about the new regulations that could provide guidelines on the manufacture and approvals, which have been missing so far. The sales that biologic agents command and the costs that they impose for payers combine to generate intense interest in the development of biogenerics.

The Challenges and Opportunities in India

The challenge now is to develop biogenerics at par with chemical counterparts. The infrastructure, academic network, technical confrontations and costs of making biogenerics are higher than for traditional chemically synthesized generics. The Department of Biotechnology is reported to spend around $200 million annually to develop biotech resources in the country, including the expansion and improvement of academic programs, the development of more and better infrastructure, the nurturing of biotech companies, and the improvement of technology transfer to businesses from universities and other noncommercial laboratories.

This is expected to bear fruits with the renewed focus on biogenerics- hailed as the future of medicine. At the same time, the biotech companies in India may look towards licensing development and marketing to western partners, as has been done by Biotech for its G-CSF biogeneric, ahead of its approvals.

With EU already having forayed into this arena and established a regulatory set up, the markets seem to be lucrative. The global market for biotech drugs grew by 18% last year and now exceeds $50 billion, which is 10% of the global pharmaceutical market at nearly three times the growth rate. The US bill is expected to simplify regulatory hurdles as well as set up a pricing strategy that would ultimately be helpful for generic companies of both countries.

Today’s Guest post is by the Group on Research, Publications and Programmes at Lex Orbis Intellectual Property Practice, Solicitors & Advocates in New Delhi, India.

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