Current regulatory and scientific considerations for approving biosimilars in Iran

Biologicals

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

  Hadavand, Naser ^a   Valadkhani, Mahboubeh ^a   Zarbakhsh, Aida ^a  

^a MINISTRY OF HEALTH AND MEDICAL EDUCATION   (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;

ARTICLE; BIOASSAY; BIOTECHNOLOGY; DRUG APPROVAL; DRUG EFFICACY; DRUG INFORMATION; DRUG LEGISLATION; DRUG MARKETING; DRUG PACKAGING; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; IRAN; LICENCE; PATENT; PHYSICAL CHEMISTRY; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; RELIABILITY; WORLD HEALTH ORGANIZATION;

ANIMALS; DRUG APPROVAL; DRUG EVALUATION; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; DRUG TOXICITY; GUIDELINES AS TOPIC; HUMANS; IRAN; PHARMACEUTICAL PREPARATIONS; WORLD HEALTH ORGANIZATION;

ANIMALIA;

EID: 80053573760     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.019     Document Type: Article

References (7)

1. Guideline on similar biological medicinal products 30 October 2005, EMEA, CHMP/437/04 Londone.
2. Guidelines on evaluation of similar biotherapeutic products (SBPs), available at http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf.
3. Guidance on Registration of Similar Biological Products in Singapore, available at http://www.biosimilars.ca/docs/Guidance_Registration_Similar_Biological_Products_Singapore.pdf.
4. Evaluation Guidelines for Biosimilars in Republic of Korea, available at http://www.biosimilars.ca/docs/Evalutation_Guidelines_for_Biosimilars.pdf.
5. Biosimilar Medicinal Products Guide, available at http://www.iegm.gov.tr/Default.aspx?sayfa=regulations%26lang=en%26thelawtype=12%26thelawId=218.
6. 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. Improving the Quality of Vaccine Production in the Islamic Republic of Iranfinal report available at http://www.who.int/immunization/GIN_October_2010.pdf.