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Up until 2002, Brazil had no specific guidance for biological products. In 2002 guidelines for biological products were published (RDC 80/2002), which had to be followed by both originator biologicals and ‘follow-on biological products’.
Original Article: Regulatory pathways for approval of biological products in BrazilNEXT ARTICLE
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...