The term "Follow-on Biologics" generally refers to a biotechnology-derived drug (or biologic) that is comparable to a novel, previously-approved biologic and that is authorized by the regulatory authorities with less supporting data than the Innovator Biologic. The FDA, US legislators, and private industry are together addressing many key issues central to patient safety, geographic market approval, patent-protection/market exclusivity, indication-specific approval, product "substitution", etc. This is an evolving process which revolves heavily around the structural and functional characterization of the molecule of interest. The need to characterize each molecule, and the depth to which it is characterized is increasing. Blue Stream is exceptionally well-suited to help with both structural characterization and cGMP release testing. Other terms used for Follow-on Biologics are Biogenerics, Biosimilars, and Generic Biologics.
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Blue Stream is well-positioned to address the analytical requirements involved in the development of Follow-on Biologics:
- Blue Stream provides fine structural and in-vitro potency characterization services and Comparability Program Management to compare an innovator biologic to the proposed Follow-on Biologic for early and late-stage product development purposes.
- Blue Stream may serve as an expert CRO for a company that is developing Follow-on Biologics. This role would be similar to one that we would serve with a traditional or innovator biotechnology Sponsor.
Please contact Blue Stream for additional information/consultation on testing programs for Follow-on Biologics (aka Biogenerics, Biosimilars, Generic Biologics).