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Positive phase III results for Mylan’s biosimilar pegfilgrastim Posted 14/10/2016

Results of a study of Biocon and Mylan’s comparing Biocon/Mylan’s biosimilar pegfilgrastim (MYL-1401H) to the originator (Neulasta) has ‘demonstrated equivalent efficacy’, according to Mylan [1].

The data was presented at the European Society for Medical Oncology (ESMO) 2016 Congress, which was held in Copenhagen, Denmark on 7–11 October 2016.

The phase III, multicentre, double-blind, randomized, parallel group study compared the efficacy and safety of MYL-1401H versus Neulasta for the prophylactic treatment of chemotherapy-induced neutropenia in patients with stage II/III breast cancer receiving neoadjuvant or adjuvant anticancer chemotherapy. It was conducted at 21 sites in Bulgaria, Georgia, Germany, Hungary, Poland and Ukraine and was completed in February 2016.

The study included 194 chemotherapy and radiotherapy naïve patients aged 18 years and over with newly diagnosed stage II/III breast cancer receiving anticancer chemotherapy (docetaxel, doxorubicin and cyclophosphamide) every 3 weeks for 6 planned chemotherapy cycles. The patients were randomized in a 2:1 ratio to receive 6 mg/0.6 mL of either MYL-1401H or Neulasta on Day 2 of each cycle.

The primary efficacy endpoint was the duration of severe neutropenia (DSN) in Cycle 1, defined as days with absolute neutrophil count (ANC) < 0.5 × 109/L in the per protocol population. Equivalence was declared if the two-sided 95% confidence interval (CI) of the least squares means difference between the DSNs fell wholly within an equivalence region defined as [-1, +1 day].

The mean ±SD for the DSN in the MYL-1401H and Neulasta groups were 1.2 ± 0.93 and 1.2 ± 1.10, respectively. The 95% CI of least squares means difference [ 0.285 day, 0.298 day] was within [-1 day, +1 day] range and was also corroborated by the sensitivity analysis in the intent-to-treat population. The overall safety profile of MYL-1401H was also similar to Neulasta with bone pain, an expected adverse event (AE), as the most frequently reported treatment-related treatment emergent AE (TEAE).

The authors therefore concluded that ‘MYL-1401H demonstrated equivalent efficacy to Neulasta in the prophylaxis of chemotherapy induced neutropenia in patients with breast cancer’. In addition, ‘MYL-1401H was generally well tolerated and there were no particular safety concerns identified with overall safety profile being similar to Neulasta’.

Mylan and Biocon announced submitted the marketing application for their proposed pegfilgrastim biosimilar (MYL-1401H) to the European Medicines Agency (EMA) in July 2016 [2]. The companies are exclusive partners on a broad portfolio of biosimilars and generic insulin analogues [3]. The proposed biosimilar pegfilgrastim is one of six biologicals being co-developed by Mylan and Biocon.

Conflict of interest
Some of the authors of the abstract [1] are employees or members of consultant/advisory board of Mylan. For full details of the authors’ conflicts of interest, see the abstract [1].

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Related article
Positive phase I results for pegfilgrastim biosimilar

1. Waller CF, et al. Phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H vs EU-neulasta® in the prophylaxis of chemotherapy-induced neutropenia. Annals of Oncology 2016;27(Suppl6):506.
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to parter on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products

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