Research
Pharmacogenomics 02/21/2018 Reapproved | AMCP supports further research and assessment of the economic, clinical, and humanistic impact of pharmacogenomics on managed care pharmacy practice. AMCP supports the pharmacist's leadership role in the review and evaluation of scientific evidence and the subsequent development of pharmaceutical care processes involving these therapies through collaboration with other health care practitioners and consumer organizations. Pharmacy and Therapeutics Committees in collaboration with Health Technology Assessment committees should be involved in the decision-making process related to coverage of genetic tests and utilization management strategies. |
| Biosimilar Drug Therapies Policy 0802 06/01/2008 Introduced 04/01/2012 Revised 10/01/2012 Reapproved | AMCP supports an abbreviated licensure pathway for the approval of biosimilar biologic drug therapies. In order to strike an appropriate balance between bringing safe and effective drugs to market and maximizing patient access to affordable drugs, the FDA should determine on a case-by-case basis the need for additional clinical studies prior to approval, as well as any post-marketing studies. Manufacturers of approved biosimilars should be allowed to use the same government-approved/international non-proprietary name as the reference product. The FDA should also provide clear rules for the designation of a biosimilar product as interchangeable with a reference product, similar to the current “AB” ratings used for small-molecule chemical drugs. A designation of interchangeability should not be a requirement as a condition for approval of a biosimilar product.
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