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Biosimilars in Oncology: Update Bulletin [May 2016]

Product Code:
Publication Date:
April 2016

This edition presents key opinion leader (KOL) views on recent developments in the oncology biosimilars market. Topics covered include Brazil’s drug regulator, Agência Nacional de Vigilância Sanitária (ANVISA) rejecting Celltrion’s application for approval of Herzuma (CT-P6; trastuzumab) as a proposed biosimilar to Herceptin, Celltrion initiating a Phase I bridging study in the US for CT-P6, which will compare the pharmacokinetics (PK) of CT-P6 to US-licensed Herceptin (trastuzumab; Roche), Pfizer publishing data for PF-06439535, a proposed bevacizumab biosimilar, from a three-arm Phase I comparative study which demonstrated the PK similarity of PF-06439535 to both EU-licensed and US-licensed Avastin (bevacizumab; Roche), and the launch of the British Biosimilars Association (BBA), a sector group of the British Generic Manufacturers Association (BGMA), which will exclusively focus on biosimilar medicines.

Key Business Questions

  • What are the potential implications of ANVISA’s rejection of Celltrion’s application for Herzuma as a proposed biosimilar of Herceptin?
  • Why has Celltrion initiated a Phase I bridging study for CT-P6 in the US? Is this simply to satisfy the FDA’s requirements, or do KOls believe there is a problem with the current data package for CT-P6?
  • Does the data from Pfizer’s Phase I study of PF-06439535, a proposed bevacizumab biosimilar, support its use as a treatment for cancer?
  • How concerned are KOLs that developers of bevacizumab biosimilars have selected lung cancer as the lead indication for late-stage development when the bulk of Avastin’s use is in the colorectal cancer setting?
  • Will organisations such as the BBA have any impact on driving better awareness on biosimilars amongst key stakeholders, or is more effort needed?


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