References

  1. INFLECTRA [prescribing information]. Incheon, Republic of Korea: Celltrion, Inc.; 2017.
  2. The Weinberg Group. FDA approves INFLECTRA™, the second US biosimilar. http://weinberggroup.com/fda-news/fda-approves-INFLECTRA-the-second-us-biosimilar/. Published April 7, 2016. Accessed September 20, 2016.
  3. Celltrion. CT-P13 (infliximab biosimilar). Briefing document for the US FDA Arthritis Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM484860.pdf. Published February 9, 2016. Accessed February 14, 2017.
  4. Ryan AM. Frontiers in nonclinical drug development: biosimilars. Vet Pathol. 2015;52(2):419-426.
  5. European Medicines Agency, European Commission. Biosimilars in the EU. Information guide for healthcare professionals. 2017. www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500226648. April 27, 2017. Accessed February 1, 2018.
  6. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419.
  7. Data on file. Pfizer Inc, New York, NY.
  8. US Food and Drug Administration. FDA briefing document. Arthritis Advisory Committee meeting. BLA 125544: CT-P13, a proposed biosimilar to Remicade® (infliximab), Celltrion. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM484860.pdf. Published February 9, 2016. Accessed February 14, 2017.
  9. US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to Reference Product. Guidance for Industry. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf. Published April 2015. Accessed December 20, 2016.
  10. Data on file. Pfizer Inc, New York, NY.
  11. Jorgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13* compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority. www.thelancet.com. 2017;389(10086):2304-2316.