• "Abbreviated” Biologics Applications: The Reality of Providing Biosimilar Products
  • September 10, 2010 | Authors: Evert Farah To Uy; Jeffrey A. Wolfson
  • Law Firm: Haynes and Boone, LLP - Washington Office
  • Biologic drug products (“biologics”) are drugs created by living organisms and biological processes. Biologics can include vaccines, allergenics, proteins or other products used to prevent, treat, or manage diseases like rheumatoid arthritis and cancer, and/or their associated conditions and symptoms. Biologics are typically large molecules with complex, unstable structures produced by complicated methods. Changing just one element in the manufacturing process or environment, such as the temperature of one particular reaction or operation, has the potential to completely change the function of the molecule.