THE PHARMACEUTICAL INDUSTRY AND REGULATION BASICS
Essential reading for critical thinkers
THE PHARMACEUTICAL INDUSTRY AND REGULATION BASICS
Product categories in the supply-chain
There are two types of drugs produced in the industry:
Small molecule - that means they are made using industrial chemistry. Aspirin is an example. The pharmaceutical industry was mainly founded on small molecule products.
Biologics (large molecule) - biologics are essentially made from living things, such as animal and human cells. A monoclonal antibody is an example. There has been rapid growth of biologics in recent years.
There are two main business models involved:
Innovators (or originators) – these are companies that carryout out the R&D and market small-molecule and/or biologic products.
Generics/Biosimilars – these are companies that copy the original innovator products, either small molecule or biologic.
Innovators develop the drugs and in so doing create the supply chains. They may do this themselves, or outsource the activites to third party contractors.
For production activites, the contractors are referred to as Contract Development and Manufacturing Organisations (CDMOs). For activities associated with running safety and clinical studies, contractors are referred to as Contract Research Organisations (CROs)