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
.
How Value-Based Care With Provider Enablement Improves Maternal and Infant Outcomes in Medicaid
June 12th 2025Supported value-based care improves prenatal care while reducing neonatal intensive care unit stays, preterm birth rates, low birth weight rates, and costs for mothers and infants.
Read More
Varied Access: The Pharmacogenetic Testing Coverage Divide
February 18th 2025On this episode of Managed Care Cast, we speak with the author of a study published in the February 2025 issue of The American Journal of Managed Care® to uncover significant differences in coverage decisions for pharmacogenetic tests across major US health insurers.
Listen