Huge Potential in Biosimilars if Generic Providers Overcome Regulatory Hurdles

Wednesday, April 23, 2008 General News J E 4
NEW YORK, April 22 Some of the biggest-selling biologicsdeveloped during the boom years in biotech of the 1980's, including humangrowth hormone (hGH) and insulin, have lost patent protection in the U.S. in2007 or will shortly, and they represent a market of $40 billion. This opensup a huge potential market for biosimilars, if regulatory hurdles can beovercome, according to a new report by Kalorama Information, Biogenerics: theWorld Market for Biosimilars.

Worldwide interest in biosimilars is gaining momentum and is expected toreach $5.8 billion by 2012. But first such stumbling blocks as safety, accessto innovators' key intermediates, process controls, availability and access tobulk materials, specifically designed and adapted analytical procedures andvalidation studies must be addressed. Also, biosimilars cannot currently bemarketed in the U.S. because there is no pathway for them to reach the market.

"Right now, there is limited competition in biosimilars due to thecomplicated regulatory process and the high costs," notes Mary Anne Crandall,senior analyst for Kalorama. "But this won't last forever, and in fact in thenear-term we should see some technological changes and political shifts thatwill fuel the market."

Biosimilars have been selling outside of the U.S. for years, creating asmall existing market. As the industry is allowed in the U.S., which Kaloramapredicts will happen in a serious way by 2009, it will grow exponentially.Growth will likely occur around a few big biopharmaceuticals at first.

Kalorama Information's report Biogenerics: the World Market forBiosimilars identifies the biopharmaceuticals that have lost patent protectionand are likely to be the first products attempted by generic companies.Current and future trends, market size and projections are also provided. Thereport can be purchased directly from Kalorama Information by visiting

About Kalorama Information

Kalorama Information supplies the latest in independent market research inthe life sciences, as well as a full range of custom research services.Kalorama routinely assists media with healthcare topics, and can provideexperts to speak about markets in the life sciences industry. For moreinformation, contact Andrea Hiller at 212-807-2673, or visit

SOURCE Kalorama Information


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