Pharmacovigilance Considerations for Biosimilars in the USA.
BioDrugs
; 29(5): 309-21, 2015 Oct.
Article
em En
| MEDLINE
| ID: mdl-26419971
ABSTRACT
In 2015, five or more biosimilars may be approved in the USA. Because no two biologic medicines are identical, postapproval safety monitoring will be critical to detect potential differences in safety signals between a biosimilar, its reference product, and other biosimilars. Postapproval safety monitoring in the USA uses two signal detection systems spontaneous reporting systems (SRSs) and active surveillance (AS) systems. Both depend on accurate identification of the specific product(s) dispensed or administered to patients, which may be compromised when products from multiple manufacturers share common drug nomenclature or coding. Product identification can present challenges across different healthcare settings, including inpatient and ambulatory care. Common oral-dosage drugs are predominantly dispensed directly to patients by pharmacists, whereas most injectable drugs, including biologics, are administered to patients by healthcare professionals in outpatient clinics or hospitals. Thus, the effectiveness of SRS and AS mechanisms in both pharmacy and medical channels must be given greater consideration as biotechnology matures. In this article, we describe these systems and their limitations. We identify challenges and opportunities for product-specific safety surveillance of biologics in both the pharmacy and medical settings and provide recommendations to improve biologic safety surveillance under the current and future systems envisioned in the Drug Quality and Security Act. As biosimilars are integrated into existing pharmacovigilance systems, distinguishable nonproprietary names and codes for all biologics, as well as other opportunities to improve traceability (e.g., increased use of barcodes), must be considered to ensure patient safety and confidence in this new class of drugs.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Sistemas de Notificação de Reações Adversas a Medicamentos
/
Medicamentos Biossimilares
/
Farmacovigilância
Tipo de estudo:
Guideline
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
BioDrugs
Assunto da revista:
ALERGIA E IMUNOLOGIA
/
GENETICA MEDICA
/
TERAPEUTICA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Estados Unidos