title: Concept of biosimilar products in Jordan.
abstract: After the expiration of patents on originator biological products, Jordanian local manufacturers and the agents of international pharmaceutical companies in Jordan started to submit registration dossiers for biosimilar products. The Jordan Food and Drug Administration (JFDA) is the national regulatory authority responsible for the registration of biosimilar products. Biosimilars are registered under the same regulations used for drugs until specific guidelines for registration of biological and biosimilar products are released. Those regulations are called Criteria of Registration of Drugs, Vaccines, Sera and Biological Products, the Renewal of its Registration and the Cancellation of Any of them which was published in the official gazette in 2004 under the Provisional Law Number 80 of the year 2001, Drug and Pharmacy Law and its amendments of the year 2003. Also, the JFDA follows the EMA guidelines on similar biological medicinal products for specific active biological substances for non-clinical and clinical studies requirements and the EMA guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. A post marketing surveillance study is requested after a biosimilar product is authorized. The JFDA keeps pace with all advances in the regulatory issues related to biosimilars in order to be capable of authorizing biosimilar products with a safe, effective and good quality profile.
authors.affiliation: Registration Department, Drug Directorate, Jordan Food and Drug Administration, Shafa Badran, Marj Alfaras, Ahmad Alkayed Al Qtaishat Street, Amman, Jordan. rania.haddadin@jfda.jo
authors.forename: Rania Dakhlallah
authors.initials: RD
authors.lastname: Haddadin
mesh_terms: D004341:Drug Evaluation / Q000331:legislation & jurisprudence* / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007597:Jordan; D007880:Legislation, Drug / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards; D011786:Quality Control
chemical_list: D004364:Pharmaceutical Preparations