NEWS & EVENTS

Editorial: Considerations for Approval of Biosimilars

Biologics_mapAlcami recently contributed to a special feature in the August / September issue of Chemicals Knowledge magazine, titled "Considerations for Approval of Biosimilars."

Biosimilars are sometimes incorrectly considered equivalent to a generic small molecule therapeutic, but for a biologic drug product, the clinical and regulatory pathways are quite different. Alcami Commercial Development Manager Cheryl Johnson explains the distinct differences in the FDA’s definition, development strategy, and regulatory approval pathways.

Read Full Article Here

 

 


Biologics

Ready to Get Started?

Connect with an Expert

 

Topics: Regulatory Compliance Biologics Editorials Parenteral Manufacturing