Understanding Biosimilars Development

The development of complex biosimilars, such as monocolonal antibodies, is an exceptionally challenging technical undertaking.  Unlike traditional small molecule pharmaceuticals which are essentially formula-driven chemicals, or simple peptides such as human growth hormone, complex biologics are much larger, multifaceted molecules.  To illustrate the relative levels of complexity, a traditional aspirin molecule can be likened to a bicycle, while a simple biologics (such as human growth hormone) can be likened to an automobile.  A complex biologic, such as a monoclonal antibody (mAb), meanwhile, is analogous to a modern commercial airliner.

                       

Aspirin Molecule

180 Daltons

Human Growth Hormone

849 Daltons

IgG Monoclonal Antibody

150,000 Daltons

 

Due to the complexity of mAb's, the requirements for establishing that a biosimilar molecule is biologically comparable to the original innovator molecule require comprehensive and exquisite science. The BioSymphony™ model for biosimilars development was specifically designed to address those scientific and regulatory requirements, within a framework of rapid, low-cost, high quality execution.