From biologicals to biosimilars

Authors

  • Shehla Shaukat
  • Tahir Jamil Ahmad
  • Ijaz Hussain

References

Müller R, Renner C, Gabay C, Cassata G, Lohri A, Hasler P. The advent of biosimilars: challenges and risks. Swiss Med Wkly. 2014;144:w13980.

FDA Draft Guidance for Industry. Quality Considerations in Demonstrating Biosimilarity to a Reference Product, 2012.

European Medicines Agency. Biosimilar Medicines, 20052014. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/document_listing/document_listing_000318.jsp. Accessed September 29, 2014.

World Health Organization. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). Expert Committee on Biological Standardization. Geneva, Switzerland. October 19-23, 2009. Available at: http:// www.managedcaremag.com/archives/2014/Katherine T Adams/biosimilars-take-centre -stage

U.S. Food and Drug Administration. Guidance for industry: Scientific considerations in demonstrating biosimilarity to a reference product. 2012 Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed December 21, 2014.

Amgen Inc. Amgen 2004 Annual report. Available at: http://library.corporateir.net/library/61/616/61656/items/143940/amgn2004AR.pdf. Accessed December 21, 2014.

Rathore N. Rajan RS. Current perspectives on stability of protein drug products during formulations, fill and finish operations. Biotechnol Prog. 2008;24:504-14

Choy E, Allen Jacobs I. Biosimilar safety considerations in clinical practice. Semin Oncol. 2014;41(Suppl. 1):S3-S14.

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Published

2016-11-18

How to Cite

1.
Shaukat S, Ahmad TJ, Hussain I. From biologicals to biosimilars. J Pak Assoc Dermatol [Internet]. 2016Nov.18 [cited 2024Dec.8];26(1):1-3. Available from: https://www.jpad.com.pk/index.php/jpad/article/view/66

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