What’s Next in the Evolution of Standards for Biologics Development

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References

Murimi-Worstell

Ballreich

Seamans

Alexander

. Association between US Pharmacopeia (USP) monograph standards, generic entry and prescription drug costs. Published: November 12, 2019. https://doi.org/10.1371/journal.pone.0225109.

Gupta

. The vital role of biological standardization in ensuring efficacy and safety of biological products–Historical perspectives. Journal of Pharmaceutical Sciences, 2025; 114(2): 690–700. https://doi.org/10.1016/j.xphs.2024.12.011.

Atouf

Venema

. Do Standards Matter? What is Their Value? Journal of Pharmaceutical Sciences, 2020; 109(8): 2387-2392. https://doi.org/10.1016/j.xphs.2020.04.017