SCOPUS 정보 검색 플랫폼

Australian Prescriber

Volumn 32, Issue 6, 2009, Pages 146-147

Biosimilars are not (bio)generics

(2) McKinnon, Ross A a Lu, Christine Y a

a UNIVERSITY OF SOUTH AUSTRALIA (Australia)

Author keywords

Bioequivalence

Indexed keywords

CONJUGATED ESTROGEN; GENERIC DRUG; HEPARIN; RECOMBINANT ANTIBODY; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN;

BIOEQUIVALENCE; DRUG EFFICACY; DRUG IMPURITY; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SAFETY; DRUG SCREENING; DRUG STRUCTURE; DRUG SURVEILLANCE PROGRAM; EDITORIAL; EUROPEAN UNION; HUMAN; IMMUNOGENICITY; PATENT; PROTEIN STRUCTURE; PURE RED CELL ANEMIA;

EID: 73949096728 PISSN: 03128008 EISSN: None Source Type: Journal
DOI: 10.18773/austprescr.2009.072 Document Type: Editorial

Times cited : (5)

References (7)

1
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- Gottlieb S. Biosimilars: policy, clinical, and regulatory considerations. Am J Health Syst Pharm 2008;65 (14 Suppl 6):S2-8.
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- Gottlieb, S.¹

2
- 0942284569
- Lessons from Eprex for biogeneric firms
- Louët S. Lessons from Eprex for biogeneric firms. Nat Biotechnol 2003;21:956-7.
- (2003) Nat Biotechnol , vol.21 , pp. 956-957
- Louët, S.¹

3
- 78851468911
- T herapeutic Goods Administration, European Union guidelines adopted in Australia, cited 2009 Nov 12
- T herapeutic Goods Administration. Clinical guidelines: European Union guidelines adopted in Australia. www.tga.gov.au/docs/html/euguide/euad-clin. htm#clinicalsimilar [cited 2009 Nov 12]
- Clinical guidelines

4
- 84875389943
- Committee for Medicinal Products for Human Use (CHMP)
- E uropean Medicines Agency, London: EMEA;, cited 2009 Nov 12
- E uropean Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. London: EMEA; 2006. www.emea.europa.eu/pdfs/human/biosimilar/4283205en. pdf [cited 2009 Nov 12]
- (2006) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues

5
- 85036799130
- Committee for Medicinal Products for Human Use (CHMP)
- E uropean Medicines Agency, London: EMEA;, cited 2009 Nov 12
- E uropean Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. London: EMEA; 2006. www.emea.europa.eu/pdfs/human/biosimilar/4934805en.pdf [cited 2009 Nov 12]
- (2006) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues

6
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- Biosimilars: It's not as simple as cost alone
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7
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- Current regulatory and legal considerations for follow-on biologics
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.