Are you hearing the term “biologic” with increasing frequency and need more details on this corner of the pharmaceutical world? Biologics are a rapidly growing sector of the drug market, composing 10 percent of new FDA approvals in 2005 and 32 percent of approvals in 2016.
Biologics and copycat biosimilars are complex protein-based pharmaceuticals that cannot be manufactured as easily as their conventional drug counterparts. Biologics are costly to produce, and are a big part of the current national drug-pricing conversation. Before 2010, there was no FDA provision for licensing cheaper analogous versions of biologics.
The Biologics Price Competition and Innovation Act introduced a path for biosimilar approval, but standards for achieving interchangeability status (allowance for the biosimilar to be substituted for the original reference biologic by a pharmacist) were strict and vague.
In January 2017, the FDA issued new interchangeability guidelines for biosimilars, making it easier to develop a biosimilar that can be ordered at the pharmacy like a generic. This guidance discusses clinical trial designs unique to the arena of biologics/biosimilars.
At the conclusion of this webinar, learners will be able to:
- Identify the differences between biologics and conventional drugs.
- Describe which regulations govern the manufacturing, approval, and distribution of biologics/biosimilars.
- Evaluate considerations exclusive to biologic/biosimilar/interchangeable clinical trial design.