This JMCP article describes how the Biosimilars Collective Intelligence Consortium (BBCIC) has the ability to coordinate sophisticated post-approval surveillance of biologics and biosimilars by utilizing its distributed research network.
This JMCP article describes how the Biosimilars Collective Intelligence Consortium (BBCIC) has the ability to coordinate sophisticated post-approval survellience of biologics and biosimilars by utilizing its distributed research network.
AMCP CEO Blog: AMCP’s roughly 8,000 members work diligently every day to improve patient care through the optimized use of medicines. As an organization, we also take a leading role in developing improvements to the overall delivery of care, which is no easy task given the size and complexity of our health care system.
Press Release: From News&Views April 2019: The Biologics Price Competition and Innovation Act (BPCIA) of 2009 created an FDA approval pathway for biosimilars that aimed to expanded patient access to these more affordable therapies.
Findings from this review indicate that health care providers approach biosimilars with caution due to limited knowledge, low prescribing comfort, and concerns over safety and efficacy. The authors of this JMCP article recommend clinician-directed education to realize the full cost-saving potential of biosimilars.
Findings from this review indicate that health care providers approach biosimilars with caution due to limited knowledge, low prescribing comfort, and concerns over safety and efficacy. The authors of this JMCP article recommend clinician-directed education to realize the full cost-saving potential of biosimilars.
On Dec 12, 2018, FDA issued a new proposal to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition Act of 2009 (BPCI Act). The BPCI Act amended the definition of biological product to include a “protein (except any chemically synthesized polypeptide.” To clarify these terms, FDA is proposing to provide its interpretation of the terms “protein” and “chemically synthesized polypeptide" to reduce regulatory uncertainty over what products are regulated as drugs or biological products.
