Biosimilar regulations and CMOs

 WEBINAR: JUNE 26 | 11AM ET/8 AM PT Biosimilar legislation passed in 2010 guaranteed 12 years of patent protection to biotechs from biosimilar competition. But passing the law was the easy part. As FDA hashes out regulations to implement the law, we help CMOs understand the significance of the legislation to their businesses and how the new legislation may help, or hurt, contract manufacturing for biologics. Register Now! Sign up for our FREE newsletter for more news like this sent to your inbox! Roche comes to the game in fairly different position. The Swiss drug giant, which currently lacks a big cardio business, seeks its first multibillion-dollar seller in this category. In May the drugmaker wrote off its experimental dalcetrapib after the drug for increasing good cholesterol bombed in a late-stage study. As Bloomberg reports, Roche has kept details about its PCSK9 drug from U.S. unit Genentech under wraps because of the intense competition in the field. Yet that will rapidly change as Roche unveils data on the program and builds its case with docs to enroll their patients in its studies. Behind Roche's and Sanofi's PCSK9 programs are several more. Amgen ($AMGN) and Pfizer are in mid-stage studies with their own candidates aimed at the hot target. Also, Bristol-Myers Squibb ($BMY), Merck ($MRK) and Alnylam ($ALNY) have research underway in the field. "These drugs allow us to go where no one has gone before," Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic in Ohio, said in an interview with Bloomberg. "There's a tremendous amount of interest among a broad range of makers of pharmaceuticals to get involved."