作者: Hugo Almeida , Maria Helena Amaral , Paulo Lobão
DOI: 10.1590/S1984-82502011000200002
关键词: Pharmaceutical industry 、 Biotechnology 、 Authorization 、 Biosimilar 、 Medicine 、 Human immunodeficiency virus (HIV)
摘要: In recent years, the number of drugs biotechnological origin available for many different diseases has increased exponentially, including types cancer, diabetes mellitus, infectious (e.g. AIDS Virus / HIV) as well cardiovascular, neurological, respiratory, and autoimmune diseases, among others. The pharmaceutical industry used technologies to obtain new promising active ingredients, exemplified by fermentation technique, recombinant DNA technique hybridoma technique. expiry patents first consequent emergence biosimilar products, have posed various questions health authorities worldwide regarding definition, framework, requirements authorization market such products.