US-based biosimilars specialist Adello Biologics has started a phase I clinical trial for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).
Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.
The single (or up to 2) centre trial will be carried out in 122 patients. The study is designed to compare Adello’s biosimilar candidate, TPI‑120 (pegfilgrastim) and Neulasta administered through the subcutaneous route in healthy adult subjects aged 19 to 55 years.
The trial, which is ‘currently recruiting participants’, according to the ClinicalTrials.gov, is a single-centre, double-blind, randomized, single dose, two-way crossover study. The aim of the study is to assess and compare the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of TPI‑120 and the US-licensed reference product, Neulasta after administering a single subcutaneous 2 mg dose in healthy adult subjects in a crossover design. The primary PK parameters are AUC0-t, AUC0-inf, and Cmax, and the primary PD parameters are baseline-corrected AUEC0-t and Emax for absolute neutrophil count (ANC).
The trial will be carried out in the US and is expected to be completed in September 2017. Adello Biologics is also carrying out another phase I trial with TPI‑120 in which it is comparing the treatment emergent incidence rate of anti-drug antibodies (ADAs) between TPI‑120 and US licensed Neulasta in normal healthy adult subjects.
The originator product, Amgen’s Neulasta (pegfilgrastim), had worldwide sales of US$4.7 billion in 2015. The patents on Neulasta expired in the US in October 2015 and will expire in Europe in August 2017 [1].
Adello Biologics are playing catch up when it comes to pegfilgrastim biosimilars. Canada-based Apotex (Apobiologix) filed for approval for its pegfilgrastim biosimilar (Lapelga) in the US in December 2014 [2]. In Europe, Biocon/Mylan applied for approval of their pegfilgrastim biosimilar (MYL‑1401H) in July 2016 [3]. Coherus submitted its application for CHS‑1701 to the European Medicines Agency (EMA) in November 2016 [4]. Finally, Stada Arzneimittel/Gedeon Richter submitted their application to EMA for approval in December 2015 [5].
There have, however, been rather a lot of setbacks when it comes to biosimilars of pegfilgrastim. Sandoz had its application rejected by the US Food and Drug Administration (FDA) in July 2016 [6] and withdrew its application from EMA in January 2017 [7]. Coherus had its application rejected by FDA in June 2017 [8].
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
4. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
5. GaBI Online - Generics and Biosimilars Initiative. Richter and DM Bio make deal for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Pharma-News/Richter-and-DM-Bio-make-deal-for-trastuzumab-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Sandoz’s biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Sandoz-s-biosimilar-pegfilgrastim-application
7. GaBI Online - Generics and Biosimilars Initiative. Sandoz withdraws biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-withdraws-biosimilar-pegfilgrastim-application
8. GaBI Online - Generics and Biosimilars Initiative. FDA rejects pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-pegfilgrastim-biosimilar-from-Coherus
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Source: Adello Biologics, ClinicalTrials.gov
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