The Lifecycles of Medicines
Module Overview
Understanding the lifecycle of medicines is a key component to understanding the pricing of innovative medicines. This module looks at that lifecycle by examining the following topics:
- Who develops innovative medicines?
- The cost of developing innovative medicines
- Biologic versus small-molecule or chemical medicines
- Biopharmaceutical company profits
- The role of intellectual property protection in pharmaceutical development
- The role of generic and biosimilar drugs versus original innovative medicines
- Why the pharmaceutical lifecycle is important to price discussions
Module Objectives
The objective of this module is to discuss the lifecycle of medicines and how that affects the overall discussion of pharmaceutical prices. Medicines face unique and important sets of review processes given how they are developed, tested and approved for use, all of which ultimately impacts their price. There are also important changes to price as a medicine moves through its lifecycle from its start as a patented, innovative medicine to becoming a multi-source generic. This process is becoming even more complex with biologic medicines and subsequent-entry biologics or biosimilars.
After completing this module, you will be able to:
- Describe who develops innovative medicines
- Discuss the cost of developing innovative medicines and who pays it
- Compare the differences between chemical and biologic medicines that impact their respective costs
- Compare pharmaceutical profits to those of other industries
- Describe the role of generic and biosimilar medicines in the pharmaceutical lifecycle