Singapore, April 23, 2008: Some of the biggest-selling biologics developed during the boom years in biotech of the 1980's, including human growth hormone (hGH) and insulin, have lost patent protection in the US in 2007 or will shortly, and they represent a market of $40 billion. This opens up a huge potential market for biosimilars, if regulatory hurdles can be overcome, according to a new report by Kalorama Information, “Biogenerics: the World Market for Biosimilars.”

 

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

 

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

 

The report notes that biosimilars have been selling outside of the US for years, creating a small existing market. As the industry is allowed in the US, which will happen in a serious way by 2009, it will grow exponentially. Growth will likely occur around a few big biopharmaceuticals at first.