AACE/ACE POSITION STATEMENT ON THE USE OF FOLLOW-ON BIOLOGICS AND BIOSIMILARS FOR ENDOCRINE DISEASES

Area of Science:

• Endocrinology
• Clinical Practice Guidelines

Background:

• Official position statement from the American Association of Clinical Endocrinologists and American College of Endocrinology.
• Addresses clinical practice where randomized controlled trials or specific U.S. Food and Drug Administration (FDA) labeling are absent.
• Defines abbreviations: Biologics Price Competition and Innovation Act (BPCIA), Food and Drug Administration (FDA), Federal Food Drug and Cosmetics Act (FFDC), Public Health Services Act (PHS), therapeutic equivalence (TE).

Purpose of the Study:

• To provide official guidance on clinical practice issues in endocrinology.
• To establish a consensus position among participating clinical experts.
• To offer recommendations where definitive evidence or regulatory guidance is lacking.

Main Methods:

• Expert consensus and clinical judgment were utilized in the absence of randomized controlled trials or specific FDA labeling.
• Efforts were made to achieve consensus among committee members.
• The document represents the official position of professional endocrinology organizations.

Main Results:

• The document outlines the official position and consensus of clinical endocrinology experts.
• Guidance is provided for clinical practice scenarios lacking robust evidence.
• Expert opinion and experience form the basis for recommendations.

Conclusions:

• Position and consensus statements offer guidance for clinicians.
• These statements are not prescriptive for individual patients.
• The ultimate judgment of a clinician remains paramount in patient care.