Biosimilars: A Global Strategic Business Report
San Jose, CA (PRWEB) March 24, 2010
Biosimilars or FOBs (Follow-on biologics) refer to generic versions of patented branded biological drugs, developed subsequent to the patent expiry of brand name products. Biosimilars are not exact copies of the original chemical medicine, but are meant to act in a similar manner as the patented biologic drug. Generally, two independently developed cell lines are not identical, and hence creating perfect duplicates of biotech medicines is impossible. Consequently, the word biosimilar has been coined to clarify the difference that biosimilars are similar but not the same as the original product.
Europe has been the first to approve the use of biosimilars in the world, as stated by the new market research report on biosimilars. The region has been the first to frame rules and regulations related to biosimilars. Several expensive biopharmaceuticals are being used for the treatment of chronic and complicated diseases in Europe, which has only added to the already increasing pharmaceutical expenditure in the region. The introduction of biosimilars, therefore, is seen as a potential opportunity to reduce government burden, and provide cost-effective drugs to several patients. And with patents of major recombinant protein classes expiring over the past years, Europe presents a lucrative opportunity for biosimilars. Few of the major product classes include monoclonal antibodies, Erythropoeitins, Interferons, and Insulin.
On the other hand, the US lacks a regulatory framework for biosimilars. However, two competing bills involving contentious issues concerning data exclusivity of the innovator product are being debated over. The region is expected to account for a major share in the global biosimilars market in future, thereby presenting lucrative prospects for biosimilar manufacturers. Increased use of biologic drugs and patent expiries are expected to help the region emerge as a potential market for budding biosimilar companies. The first-generation generic products to enter the US market include Human Growth Hormone and insulin, while the second-generation products include recombinant DNA and protein treatments.
Both the US and European markets are characterized by the presence of big, eminent players in the biosimilar drugs arena. Biosimilar manufacturing is an extremely risky process requiring strong clinical-trial capabilities, robust R&D expertise, huge financial backup and manufacturing know-how. As such, smaller companies rarely have access to these to produce biosimilars. Key players profiled in the report include Biocon Ltd., Biopartners GmbH, Cipla Ltd., Dr. Reddy's Laboratories Ltd., Hospira Inc., Intas Biopharmaceuticals Ltd., Sandoz International GmbH, Shantha Biotechnics Ltd., Teva Pharmaceutical Industries Ltd., and Wockhardt Ltd., among others.
The report titled "Biosimilars: A Global Strategic Business Report" announced by Global Industry Analysts, Inc., provides a comprehensive review of the market, growth drivers, growth restraints, challenges, regulatory framework, patent expiries of biologics, product approvals/launches, recent industry activity. The study analyzes market data and analytics in terms of value sales for regions including The United States, Japan and Europe (further analyzed by region, including France, Germany, UK, Spain and Rest of Europe). Biosimilars market is also analyzed in terms of drug classes, including Epoetin Alpha, Granulocyte colony-stimulating factor, Human Growth Hormone, Interferon, and Insulin.
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About Global Industry Analysts, Inc.
Global Industry Analysts, Inc., (GIA) is a reputed publisher of off-the-shelf market research. Founded in 1987, the company is globally recognized as one of the world's largest market research publishers. The company employs over 800 people worldwide and publishes more than 1100 full-scale research reports each year. Additionally, the company also offers thousands of smaller research products including company reports, market trend reports, and industry reports encompassing all major industries worldwide.
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