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ESMO 2019 Showcases Biosimilar Equivalency Data

Gina Columbus @ginacolumbusonc
Published: Friday, Oct 11, 2019

At the 2019 ESMO Congress, the oncology community was brought up to speed on clusters of data with biosimilars. The findings showcased that biosimilars for pegfilgrastim (Neulasta), filgrastim (Neupogen), bevacizumab (Avastin), and trastuzumab (Herceptin) demonstrated efficacy and safety equivalency with their reference counterparts in a number of malignancies.

In the per-protocol set, the best ORR was 50.1% with the biosimilar and 44.8% with bevacizumab. The risk difference was 5.3% (95% CI, −2.2%-12.9%], of which the lower margin was contained within and the upper margin was outside the predefined equivalence margin of (95% CI, −12.5%-12.5%). The biosimilar demonstrated equivalency with reference bevacizumab with other efficacy endpoints, safety, PK, and immunogenicity.

References

  1. Phelip JM, Souquet P-J, Bordenave S, et al. Modalities of biosimilar filgrastim use in clinical practice in > 1000 patients receiving chemotherapy regimens with a rest period of ≤ 14 days: The TOPAZE study. Ann Oncol. 2019;30(suppl_5). doi: 10.1093/annonc/mdz265.057.
  2. Velinova M, Bellon A, Nakov R, et al. Randomized, double-blind, cross-over phase I study comparing pharmacokinetics, pharmacodynamics, safety and immunogenicity of a biosimilar pegfilgrastim with EU and US references. Ann Oncol. 2019;30(suppl_5): doi: 10.1093/annonc/mdz265.060.
  3. Stebbing J, Baranau Y, Baryash V, et al. 3-year follow-up of a phase III trial comparing the efficacy and safety of neoadjuvant and adjuvant trastuzumab and its biosimilar CT-P6 in HER2 positive early breast cancer (EBC). Ann Oncol. 2019;30(suppl_5). doi: /10.1093/annonc/mdz240.016.
  4. Xu B, Zhang W, Sun T, et al. Efficacy and safety of first China-manufactured trastuzumab biosimilar HLX02 for metastatic breast cancer: a phase III trial. Ann Oncol. 2019;30(suppl_5). doi: 10.1093/annonc/mdz242.004.
  5. Reck M, Luft A, Bondarenko I, et al. A phase III study comparing SB8, a proposed bevacizumab biosimilar, and reference bevacizumab in patients with metastatic or recurrent non-squamous NSCLC. Ann Oncol. 2019;30(suppl_5). doi: 10.1093/annonc/mdz260.087.

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