Specialty Pharmacy/Biosimilars
| Specialty Pharmaceuticals and Related FDA Approved Products Policy 0112 03/01/200 Introduced 02/01/2006 Revised 12/01/2010 Revised 02/21/2021 Revised | AMCP supports the leadership role of pharmacists within specialty pharmacy, including ensuring the proper use, storage, control, safe handling, preparation, distribution, administration, and care management processes for these medications. Specialty pharmaceuticals are generally high-cost medications, usually prescribed for people with complex or chronic medical conditions, or they may be medications that typically exhibit one or both of the following characteristics: • drugs that have unique monitoring, storage, or shipment requirements; and • drugs that require additional patient education and support from a health care team which includes a pharmacist with specialty medication experience.
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| Restricted Distribution of Pharmaceuticals Policy 0119 11/01/2001 Introduced 02/01/2006 Revised 12/01/2010 Revised 04/07/2015 Revised | AMCP generally opposes any restrictions on the distribution of pharmaceutical products either by the pharmaceutical industry or as a condition for FDA-approval. AMCP acknowledges that circumstances may occur with the use of specific medications that require special distribution, monitoring and management processes. As long as, 4. There is scientific consensus that the requirements are necessary and represent the least restrictive means to achieve safe and effective patient care; 6. All requirements are stated in functional, objective terms so that any provider who meets the criteria may participate in the care of patients; 7. The requirements do not interfere with the professional practice of pharmacists, physicians, or other appropriately qualified healthcare professionals. |
| 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. (See AMCP Where We Stand Position Statement – Biosimilar Drug Therapies) |
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