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Volumn 39, Issue 5, 2011, Pages 325-327

Current regulatory and scientific considerations for approving biosimilars in Iran

Author keywords

Biosimilars guideline; Follow on biologics; Iran; Similar biological medicinal products; Subsequent entry biologics; WHO

Indexed keywords

BIOLOGICAL PRODUCT; GENERIC DRUG; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN; RIBOSOME DNA;

EID: 80053573760     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.019     Document Type: Article
Times cited : (6)

References (7)
  • 5
    • 84856800869 scopus 로고    scopus 로고
    • available at .
    • Biosimilar Medicinal Products Guide, available at http://www.iegm.gov.tr/Default.aspx?sayfa=regulations%26lang=en%26thelawtype=12%26thelawId=218.
    • Biosimilar Medicinal Products Guide
  • 6
    • 84856791246 scopus 로고    scopus 로고
    • Drug Master File Requirements for the Registration of Biosimilars in Saudi Arabia, available at .
    • Drug Master File Requirements for the Registration of Biosimilars in Saudi Arabia, available at http://www.sfda.gov.sa/NR/rdonlyres/854D2AFE-E362-4027-B9C4-30600431EBD5/0/Guidelinesonbiosimilars.pdf.
  • 7
    • 84856769016 scopus 로고    scopus 로고
    • Improving the Quality of Vaccine Production in the Islamic Republic of Iranfinal report available at .
    • Improving the Quality of Vaccine Production in the Islamic Republic of Iranfinal report available at http://www.who.int/immunization/GIN_October_2010.pdf.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.