Ensuring the Safety of Biosimilars vs. Branded Biologics


Alison Armstrong, Director of Development Services

Alison Armstrong, Director of Development Services

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.

 

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