Biosimilars are drugs with active ingredients that have been made by or derived from a living organism. In essence, they use recombinant DNA or controlled gene expression to mimic the behavior of an “innovator” biologic and can also be referred to as “follow-on biologics”. While they offer a comparable product to branded biologics both in functionality and structure, their complexity requires careful measurements and studies to ensure the therapeutic is similar in terms of quality, safety, and efficacy.
A recent article published in Pharmaceutical Technology Europe by Alison Armstrong, Director of Development Services at BioReliance gives insight into the procedures and various studies performed when producing regulatory-approved biosimilars.
To learn more about BioReliance’s work with biologics, please visit www.bioreliance.com.