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Industry Voices: Biosimilars and Trade Secrets
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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The Biden administration recently launched the Global Health Security Strategy, a new effort to combat the spread of infectious diseases; lawmakers zeroed in on the risks of massive consolidation in health care during the first congressional hearing on the Change Healthcare hack; the FDA recently announced the recall of a pair of heart devices linked to numerous deaths and injuries.
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Navigating Health Policy in an Election Year: Insights From Dr Dennis Scanlon
April 2nd 2024On this episode of Managed Care Cast, we're talking with Dennis Scanlon, PhD, the editor in chief of The American Journal of Accountable Care®, about prior authorization, price transparency, the impact of health policy on the upcoming election, and more.
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