Trade secrets may potentially be used to protect manufacturing processes for biological drugs--yet there is concern that the new law on biosimilars, the BPCIA (Biologics Price Competition and Innovation Act of 2009), and the accompanying FDA regulations, may expose trade secrets of both originators and biosimilar applicants.
Trade secrets may potentially be used to protect manufacturing processes for biological drugs--yet there is concern that the new law on biosimilars, the BPCIA (Biologics Price Competition and Innovation Act of 2009), and the accompanying FDA regulations, may expose trade secrets of both originators and biosimilar applicants.
Manufacturing processes for biologics include many aspects that could be kept as trade secrets, including precise cell growth conditions, analytical processes, purification process and even characteristics of the cells that produce the drug.
Source: FierceBiotech
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Examining Telehealth Uptake to Increase Equitable Care Access
January 26th 2023To mark the publication of The American Journal of Managed Care®’s 12th annual health IT issue, on this episode of Managed Care Cast, we speak with Christopher M. Whaley, PhD, health care economist at the RAND Corporation, who focuses on health economics issues, including the influence of the COVID-19 pandemic on health care delivery.
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