메뉴 건너뛰기




Volumn 39, Issue 5, 2011, Pages 321-324

Biosimilars and non-innovator biotherapeutics in India: An overview of the current situation

Author keywords

Biosimilar products; Copy products; Developing country; India; Non innovator products

Indexed keywords

ALPHA INTERFERON; BETA INTERFERON; BEVACIZUMAB; BIOLOGICAL PRODUCT; CHORIONIC GONADOTROPIN; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; ETANERCEPT; FOLLITROPIN; GRANULOCYTE COLONY STIMULATING FACTOR; HUMAN GROWTH HORMONE; HUMAN MENOPAUSAL GONADOTROPIN; INFLIXIMAB; INTERLEUKIN 2; LUTEINIZING HORMONE; PALIVIZUMAB; PARATHYROID HORMONE; PEGINTERFERON ALPHA; RECOMBINANT ERYTHROPOIETIN; RITUXIMAB; STREPTOKINASE; TISSUE PLASMINOGEN ACTIVATOR; TRASTUZUMAB;

EID: 80053568200     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.018     Document Type: Article
Times cited : (28)

References (11)
  • 1
    • 84856779812 scopus 로고    scopus 로고
    • Guidelines on evaluation of similar biotherapeutic products (SBPs):
    • Guidelines on evaluation of similar biotherapeutic products (SBPs): http://www.who.int/biologicals/publications/trs/areas/biological_therapeutics/guidelines_biotherapeutic_products_final_hk_ik_12_june.pdf.
  • 4
    • 84856768313 scopus 로고    scopus 로고
    • Indian biogeneric companies on the threshold of globalization
    • Indian biogeneric companies on the threshold of globalization. Biospectrum June 2007, 5(6). http://www.biospectrumasia.com/content/130808ind6791.asp.
    • (2007) Biospectrum , vol.5 , Issue.6
  • 5
    • 84856795116 scopus 로고    scopus 로고
    • The Mashelkar Committee report on recombinant pharmaceuticals:
    • The Mashelkar Committee report on recombinant pharmaceuticals: http://cdsco.nic.in/html/Final%2520Report%2520mashelkar.pdfug.
  • 6
    • 84856801155 scopus 로고    scopus 로고
    • Biotechnological/biological products - central drug standard control organization guidance document for industry:
    • Biotechnological/biological products - central drug standard control organization guidance document for industry: http://cdsco.nic.in/CDSCO-GuidanceForIndustry.pdf.
  • 7
    • 84856784876 scopus 로고    scopus 로고
    • The Indian Pharmacopoeia (IP) 2010, http://ipc.nic.in/writereaddata/linkimages/New%2520Features%2520of%2520IP%252020107592310671.pdf.
    • (2010) The Indian Pharmacopoeia (IP)
  • 8
    • 84856779810 scopus 로고    scopus 로고
    • Huge potential savings from biogenerics:
    • Shapiro R. Huge potential savings from biogenerics: http://www.thefreelibrary.com/Huge%2Bpotential%2Bsavings%2Bfrom%2Bbiogenerics%253A%2Ba%2Breport%2Bby%2Beconomist%2BDr.-a0199538731.
    • Shapiro, R.1
  • 9
    • 70049109465 scopus 로고    scopus 로고
    • Binocrit: assessment of quality, safety and efficacy of biopharmaceuticals
    • Brockmeyer C. Binocrit: assessment of quality, safety and efficacy of biopharmaceuticals. EJHP Practice 2009, 15:24-40.
    • (2009) EJHP Practice , vol.15 , pp. 24-40
    • Brockmeyer, C.1
  • 10
    • 33748921915 scopus 로고    scopus 로고
    • Biophysical comparability of the same protein from different manufacturers: a case study using Epoetin alfa from Epogen and Eprex
    • Deechongkit S., Aoki K., Park S., Kerwin B. Biophysical comparability of the same protein from different manufacturers: a case study using Epoetin alfa from Epogen and Eprex. J Pharm Sci 2006, 95:1931-1943.
    • (2006) J Pharm Sci , vol.95 , pp. 1931-1943
    • Deechongkit, S.1    Aoki, K.2    Park, S.3    Kerwin, B.4
  • 11
    • 77949561620 scopus 로고    scopus 로고
    • How similar are biosimilars in India? A blind comparative study
    • Mody R., Goradia V., Gupta D. How similar are biosimilars in India? A blind comparative study. Pharma Focus Asia 2009, 11:40-49.
    • (2009) Pharma Focus Asia , vol.11 , pp. 40-49
    • Mody, R.1    Goradia, V.2    Gupta, D.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.