R&D EXPANSIONS
Biopharmaceutical multinationals are offshoring increasingly large slices of R&D. In addition to developing R&D capabilities
to support its own innovators, India aims to compete with China, Singapore, Korea, and other fast-growth nations to capture
as much of that market share as it can. In 2008, plans for major new R&D facilities were announced by companies including
Avesthagen in Bangalore, Panacea Biotec in Mumbai, and Biocon in Punjab. Furthermore, biotech parks with R&D facilities, such
as Bangalore Helix and the Genome Valley expansion, continued to proliferate. A state-of-the-art vaccine R&D center, to be
run as a joint nonprofit venture by Emory University and an Italian biotech NGO, is also under construction.
PRODUCTION CAPACITY INCREASE
In the past year, Dr. Reddy's began work on a new 5,000-L biologics manufacturing facility in Andhra Pradesh; Mumbai-based
USV began building a 3,000-vial-per-hour injectables facility at Daman; Avesthagen began building a biosimilars plant in Bangalore;
and the government continued work on a major vaccine park in Chennai. Intas became India's first and only local biopharmaceutical
company to receive EU GMP certification at its Ahmedabad facility, and aims to bring a range of oncology biogenerics to the
European market soon.
PRODUCT AND COMPANIES NEWS
Bangalore-based Biocon has grown so swiftly that it is now ranked among the top 20 global biopharmaceutical firms and is the
only Asian company with this distinction. The company saw its revenues from both biologicals and contract research services
grow strongly during the year, even as profit margins were pinched by the effects of rupee volatility on export contracts
and by falls in licensing revenue. Biocon announced a number of new product-related developments in 2008, including an apparently
safer American-made prefilled syringe for its EPO and GCSF products, and early-stage clinical trials for its hoped-for oral
insulin blockbuster, as well as a monoclonal antibody against rheumatoid arthritis and psoriasis.
The company underlined its intention to market its own products in Western markets by acquiring, in February, a 70% stake
in Germany-based AxiCorp for €30 million. However, rumors put out by the company in April, suggesting an imminent acquisition
of an unnamed American marketer, failed to materialize.
Panacea Biotec reported falling revenues around the middle of the year but in August received a $34-million contract from
UNICEF for its EasyFive pentavalent vaccine against diphtheria, tetanus, pertussis, hepatitis B, and hemophilus influenzae
B.
Intas Pharma and its venture partner, Europe-based Kwizda, completed a Phase 1 clinical trial of Neukine, a biogeneric GCSF.
The companies hope to file for EU approval by early 2010. Intas also formed a venture with Canadian firm Apotex to co-develop
and market the product in North America.
The ranks of Indian biopharmaceutical companies meanwhile continued to expand. Venkateswara Hatcheries, known as producers
of veterinary products, announced plans to form a human biopharmaceuticals unit, Uttara Biosciences, to focus initially on
the development of oncology therapies.
CONCLUSION
India's biopharmaceutical industry is managing to do quite well by leveraging the strength of contract research plus local
and regional sales of insulin and other off-patent, big-market biologics. It is slowly but surely positioning itself to do
much better.
The current economic downturn in North America and Europe has the potential to hasten the transfer of basic R&D, clinical
research, and manufacturing activities to India and other low-cost, high-technology countries.
Meanwhile, India-made biogenerics are competing in the Indian domestic market and are increasingly being sold in other lightly
regulated markets such as the Middle East, Africa, and Asia. Now open to biogenerics, Europe is the next big target, and legislation
to enable biogenerics approvals in the US is possible in the next administration, where an emphasis on healthcare cost cutting
is expected. Further into the future lies growth driven by innovative drugs, vaccine initiatives, bioinformatics expertise,
and clinical trials prominence.
Eric Langer is president and managing partner at BioPlan Associates, Inc., Rockville, MD. He is also the editor of Advances in Biopharmaceutical Technology in India, 301.921.5979, elanger@bioplanassociates.com
REFERENCES
1. BioPlan Associates. Advances in Biopharmaceutical Technology in India. Inc. Rockville MD; 2008.
2. India Biopharmaceutical Newsletter. BioPlan Associates. 2008 Dec.
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