Resources

References

  • For full prescribing information refer to the Professional Information as approved by the Medicines Regulatory Authority
  • US Food and Drug Administration. Biosimilar product regulatory review and approval. https://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/
  • approvalapplications/therapeuticbiologicapplications/biosimilars/ucm581309.pdf. Accessed July 20, 2018.
  • As per the schedule of medicines from the National Department of Health, dated 03 November 2021.
  • US Food and Drug Administration. Biological product definitions. https://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/
  • therapeuticbiologicapplications/biosimilars/ucm581282.pdf. Accessed August 2, 2018
  • US Food and Drug Administration. Biosimilars: Additional questions and answers regarding implementation of the biologics price competition and innovation act of 2009. Draft Guidance for Industry. May
  • https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm273001.pdf. Accessed June 15, 2018.
  • US Food and Drug Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. Guidance for Industry. December 2016. https://www.fda.gov/downloads/
  • drugs/guidancecomplianceregulatoryinformation/guidances/ucm397017.pdf. Accessed August 3, 2018
  • US Food and Drug Administration. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Guidance for Industry. April 2015. https://www.fda.gov/ucm/
  • groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm291134.pdf. Accessed May 14, 2018.
  • US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for Industry. April 2015. https://www.fda.gov/downloads/drugs/guidances/ucm291128.
  • Accessed June 14, 2018.
  • US Food and Drug Administration. Labeling for biosimilar products. Guidance for Industry. July 2018. https://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm493439.
  • Accessed August 2, 2018.
  • US Food and Drug Administration. Overview of the regulatory framework and FDA’s guidance for the development and approval of biosimilar and interchangeable products in the US. https://www.fda.gov/
  • downloads/aboutfda/workingatfda/fellowshipinternshipgraduatefacultyprograms/ pharmacystudentexperientialprogramcder/ucm587522.pdf. Accessed September 7, 2018.
  • Eisenstein M. Bring on the biosimilars. Nature 9 May 2019, vol 569. Video at Go.Nature.Com/2GEAZEU
  • Apsangikar P, Chaudhry S, Naik M, Deoghare S and Joseph J. Comparative Study for Efficacy and Safety of Biosimilar Infliximab in Patients with Active Rheumatoid Arthritis on a stable Dose of
  • J Arthritis Rheumatol Res 1(1): 101 Citation 2018
  • Lambert J, Wyand M, Lassen C, Shneyer L. Bioavailability, safety and immunogenicity of biosimilar infliximab (BOW015) compared to reference infliximab. International Journal of Clinical Pharmacology and
  • Therapeutics, Vol. 54 – 4/2016 (315-322)
  • Delivering on the potential of Biosimilar Medicines: The role of functioning competitive markets. IMS Institute for Healthcare Informatics. March 2016. The full report is available at QuintilesIMSInstitute.org
  • Biosimilar Medicines Group; Biosimilar Medicines Handbook; 2016
  • European Medicines Agency and the European Commission; Biosimilars in the EU – information guide for healthcare professionals; 2019
  • European Commission; What I need to know about Biosimilar Medicines – Information for patients; 2016
  • Moffitt D, Explainer: 10 things to know about monoclonal antibodies; CSL Behring; 07 Jul 2020; accessed on 24 September 2021; available from https://www.cslbehring.com/vita/2020/explainer-10-things-to-know-about-monoclonal-antibodies
  • Mayo Clinic Staff; Monoclonal antibody drugs for cancer: How they work; The Mayo Clinic; 20 Sep 2019; accessed on 20 Sep 2021; available from https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808
  • DrugBank Online; Infliximab; Drugbank; updated 19 Sep 2021; accessed on 24 Sep 2021; available from https://go.drugbank.com/drugs/DB00065
  • Kishore K, Krishan P; Pharmacology of recombinant or genetically engineered drugs; Journal of Young Pharmacists; 2009; 1(2): 141-150
  • South African Rheumatism and Arthritis Association; Biologics Registry; accessed on 11 October 2021; available from https://saraa.co.za/biologics-registry/
  • South African Gastroenterology Society; SAGES Inflammatory Bowel Disease Registry Study Protocol; accessed on 11 October 2021; available from https://www.sages.co.za/content/newsletter_SAGES/IBD_Registry_Protocol.pdf