Immunology and Biotherapies

The development of complex biosimilars, such as monocolonal antibodies and fusion proteins, is an exceptionally challenging technical undertaking.  Unlike traditional small molecule pharmaceuticals which are essentially formula driven chemicals, 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.

 

Due to the complexity of mAb’s and fusion proteins, 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, as illustrated below.

 

  

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