May 16, 2012
After testifying before the FDA on May 11, Inside Health Policy quoted ASBM chairman Dr. Dolinar. Biologics makers peg biosimilars areas they want clarified: Alliance for Safe Biologics chairman Richard Dolinar said, “Biologics are complex, large molecule drugs that are grown inside living cells using unique and proprietary processes. For this reason no two biologics […]
April 11, 2012
By Dr. Richard Dolinar Chairman of the Alliance for Safe Biologic Medicines (Published April 5, 2012) Excerpt: Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that the FDA was rightly focused […]
December 14, 2010
Biologic drugs are often referred to as ”miracle drugs“ for good reason…
December 14, 2010
Biologic drugs are often referred to as ”miracle drugs“ for good reason…
November 7, 2010
For cancer patients, what is the “acceptable risk” that a drug will pose safety risks or won’t work properly?
