SOURCE: Kalorama Information

Kalorama Information

August 05, 2009 15:22 ET

As Approval Nears, Biosimilar Makers Eye Potential $45 Million U.S. Market

NEW YORK, NY--(Marketwire - August 5, 2009) - Fierce competition could open up between producers of generic biopharmaceuticals -- widely known as biosimilars or biogenerics -- and branded biopharmaceuticals if Congress approves these drugs in the U.S., according to a new report from leading healthcare science publisher Kalorama Information. The report says that U.S. approval, which is expected this year, would unleash the efforts of a few experienced and strongly funded competitors, creating a U.S. market for biosimilar drugs that could reach $45 million by 2015.

Biosimilars are considered the generic product form of natural biologic substances, including proteins such as enzymes or antibodies, and nucleic acids such as DNA or RNA. Unlike generic pharmaceuticals, there are no truly exact biologic generics due to the complex process of creating biopharmaceuticals, so generic products are either similar in nature or in some cases improvements over the original. There currently is no pathway for these products in the U.S. market, but recent House and Senate committee approvals portend market approval by next year. Generic likely to enter the U.S. are first generation products such as hGH and insulin, as well as second generation products such a protein and recombinant DNA treatments.

"It's a small group of companies who have the knowledge and funding to be able to pull off the biosimilar concept in the EU and elsewhere," said Bruce Carlson, publisher of Kalorama Information. "But for that reason, they are also the most experienced, and they will hit the ground running in the U.S. once approval is granted."

Some of the leaders emerging in the market are Cangene, Biocon, Sandoz, TEVA, Dr. Reddy's. Having successfully marketed biogeneric products in Europe and Asia, these companies will come to the new market ready. Among biological products likely to be challenged: Amgen's chemotherapy drug Neuopogen, which stimulates production of white blood cells and is challenged by TEVA Pharmaceutical among others, and Genentech's Rituxan, a protein used in the treatment of rheumatoid arthritis and non-Hodgkins lymphoma that is challenged by Dr. Reddy's biosimilar product Reditux which is currently marketed in the E.U.

"Expect fierce competition, heavy advertising and legal battles over patents as biogeneric products attack and branded biodrugs defend," said Carlson. "We haven't seen this kind of competition in the U.S. biopharmaceutical market, these drugs have competed only with other types of more traditional treatments based on their efficacy and cost, but this will change as of 2010."

The House Committee on Energy and Commerce and the Senate Health, Education, Labor and Pensions Committee have cleared a regulatory pathway for biological generic drugs, or biosimilars, and it is widely expected that biosimilar legislation will pass the whole Congress in the next legislative session. Once that occurs, Kalorama Information expects biosimilars, despite their differences with traditional generics, to follow roughly the pattern of generic drugs -- initial slow sales followed by confidence and acceptance.

Kalorama Information's new report, "The World Market for Biosimilars and the Potential for U.S. Follow-On Biologics," provides an in-depth look into the state of the biosimilars industry in the U.S. The report covers legislation, market size, forecasts, reviews of biological drugs with expiring patents, profiles of major competitors in biogenerics and more. For further information visit:

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