Affiliation:
1. Evidence-Based Therapeutic Group, Clinical Pharmacology, Universidad de la Sabana, Chia, Colombia
2. Riesgo de Fractura S.A. Cayre IPS, Bogota, Colombia
Abstract
Developing new biologics has led to regulations and norms aimed at guaranteeing their
safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability and
switching. Biologics are of great importance in treating patients suffering from rheumatic, autoimmune,
inflammatory and neoplastic diseases. The expiry/lapse of reference biologics or originators’
patents has meant that developing biosimilars involves accompanying legal requirements for their
approval in countries worldwide. This paper has thus approached the situation of biosimilar regulation
worldwide, the pertinent technical concepts and regulatory differences in some countries of
interest.
Funder
Colombian Science, Technology and Innovation Department (Colciencias)
Publisher
Bentham Science Publishers Ltd.
Subject
Pharmacology (medical),General Pharmacology, Toxicology and Pharmaceutics,General Medicine
Cited by
5 articles.
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