Strategies For Biosimilars Development

By Thomas Moehler, MD, PhD, Dannelle Palmer, MBA, PMP, Richard Jones, MD, Carolyn Finkle, Shannon Williams, George Scott, PhD and Mario Tanguay, PhD

The U.S. biopharmaceutical market recently experienced a watershed moment: a 21-3 Advisory Committee vote in February 2016 to approve the first monoclonal antibody biosimilar. CT-P13, Celltrion’s biosimilar to Remicade® (infliximab), targets autoimmune diseases, including Crohn’s disease, ulcerative colitis and rheumatoid arthritis.

In September 2015, the first biosimilar made its way into the market—Zarxio™ (filgrastim-sndz) produced by Sandoz. A number of other biosimilars are in development as patent expirations loom on many more blockbuster biologics. Indeed, sponsors already have filed with the Food & Drug Administration (FDA) for approval of several biosimilars, such as Amgen’s ABP 501, a biosimilar version of Humira®, and Sandoz’ proposed biosimilar of Enbrel®.