Report From: India - Pharmaceutical Technology

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Pharmaceutical companies in India have had a hold on the biotechnology sector for many years, and they're not about to let the follow-on biologics market pass them by.


Pharmaceutical Technology
Volume 33, Issue 10, pp. 18-28

It's boom time for the Indian biotechnology sector, which has grown more than 30% during the past five years and is expected to be worth $20–$25 billion in revenue by 2015, according to industry estimates and market research reports. Behind the boom stands global pressure to lower healthcare costs. Governments far and wide—including in India—are trying to facilitate the entry of less expensive, generic biotechnology or protein-derived drugs, also known as follow-on biologics, biosimilars, or biogenerics.

"Biogenerics represent a major future opportunity in economic terms for India and, more importantly, for products at reasonable costs, because an unprecedented number of blockbuster drugs are going off patent,'' says Rajesh Jain, joint managing director of the biopharmaceutical firm Panacea Biotech (New Delhi).

An estimated $25 billion worth of innovator biologics are set to lose patent protection by 2016, according to a report on "The Top 10 Biosimilar Players" in Business Insights that notes IMS estimates, and large Indian biotechnology firms are anxiously awaiting the opportunity to develop follow-on versions. Vaccines are, of course, a major part of this particular sector. The country's vaccine sector is growing at a rate of 25–30% per year, and is projected to reach more than $1 billion in sales by 2012, according to Navroz Mahudawala, director of Ernst & Young's health sciences practice.

Domestic firms seek a piece of the action

Deals to secure a share of the follow-on biologic marketplace are coming in thick and fast. On Sept. 7, 2009, Cipla (Mumbai) entered into a 50–50 joint venture with Chinese pharmaceutical company Zheijang Aotuokang for the manufacture of follow-on biologics. The new venture will focus on an arthritis product based on a Johnson & Johnson (New Brunswick, NJ) innovator drug and a cancer treatment drug. The joint venture is to be called Biomab, and Cipla expects the initial product to be out by the first quarter of 2010.

Biotechnology firm Avesthagen (Bangalore) has developed several follow-on biologics and has four molecules ready for clinical trials. The firm is not yet listed on the Indian stock market but is preparing for its initial public offer (IPO). "Many people are interested in our molecules and products,'' says Villoo Morawala-Patell, chairman of Avesthagen, which expects to reach a turnover of $20 million from R&D and the sale of nutritional products. The company holds 560 patents and expects to license some of its plant-derived nutritional and therapeutic molecules and ingredients by the end of 2009.

Biocon (Bangalore) executed a definitive agreement with Mylan (Pittsburg, PA) in June 2009 for an exclusive collaboration on the development, manufacture, and commercialization of multiple, high-value generic biologic compounds for the global marketplace. "The complexity and costs involved in developing generic biologics are expected to see only a few players being able to gain entry into the highly regulated markets of Europe and USA,'' says Chairman Kiran Mazumdar-Shaw, adding that the deal with Mylan would "accelerate our work in generic biologics and take it to the next level around the world.''


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