Moving forward clinical studies will have to include a comparative assessment of
pharmacokinetics and immunogenicity to the original reference biologic drug
Stephanie Mowery, Sherri Rinker, Franklin Spriggs and Bo Kowalcyk , AIT Bioscience06.02.15
More than $60 billion worth of patents on biological products are expiring before 2020, representing a major opportunity for the pharmaceutical industry.
Patricia Hurley, Joan Boren and Costantino Congiatu, PPD06.02.15