A biosimilar must be similar to the innovator product, but there is some scope to differentiate your biosimilar from the crowd. Differentiation can be achieved through novel formulations and presentations such as an innovative delivery device. The EU regulatory system is more flexible than that of the US, allowing for the potential to introduce new routes of administration. Additional ways to make your biosimilar stand out are to build relationships with prescribers and offer support services to make life easier for prescribers, health care workers, and patients. Examples of support services are the provisioning of apps that help manage patient care and access to other information resources. In the US, a biosimilar approved as interchangeable can make your biosimilar stand out from the crowd. Interchangeability is most valuable for self-administered products supplied through community pharmacies but comes at a price of requiring a more extensive data package than a standard biosimilar. Finally, generating and publishing clinical data that serves to support prescriber confidence adds value. In this respect, education on the concepts of biosimilarity can also help gain market access.
At the conclusion of this short course, participants should be able to:
- Formulate a strategy for differentiating you biosimilar from the crowd
- Develop a strong program to inform and support prescribers, health care workers and patients to safely use their medicine and best manage their condition
- Apply local regulatory opportunities to maximize the potential of your biosimilar while recognizing the limitations