Lonza and Teva announced today that they will be ending their short-lived venture to jointly develop biosimilars. Senior Lonza executives say that developing biosimilars is expected to be too costly and take too long to bring to market given current regulaory policy (e.g. FDA guidelines). So given new the newer regulatory information that emerged after the JV was started, Lonza assessed it and decided to get out. Lonza says it will stick to its core expertise in the CMO business.
Teva for its part has said it will continue to play in the biosimilar market by pursuing a "highly selective approach in our efforts to create a balanced portfolio of biosimilars, biobetters, and innovative biologics....."
Bottom line: FDA regulations calling for liklihood of clinical trials with most biosimilar applications is deemed to be more expensive and time consuming than previously thought and will scare some players out of the market. Lonza is first to go. See Fierce Biotech and In-PharmaTechnologist.
Posted by Bruce Lehr July 25th 2013.