2 min read
Alcami 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.
4 min read
Parenteral Market Trends
With today’s growing pipeline of biologics, namely complex oncology products often delivered parenterally, and COVID vaccine production, there is...
3 min read
Outsourcing Trends in the Development of Biologics
The development of biologic drugs continues to increase at a rapid pace. Growing numbers of conventional recombinant proteins and monoclonal...