Pegfilgrastim

Refrigerated StorageLactation Safety InformationNew Medicines ·
388379009

Refrigerated Storage

NeulastaAmgen Ltd

Amgen Ltd
Neulasta
6mg solution for injection in pre-filled syringe and with on-body injector

In the event of an inadvertent temperature excursion the following data may be used:
Neulasta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours, after which it should be discarded.
The pre-filled syringe with the on-body injector may be exposed at room temperature for no longer than 36 hours prior to filling the on-body injector.
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Neulasta.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact Amgen Ltd in cases where additional stability data is required. Refer to the current BNF for company contact details.

72 hours if exposed up to 30°C
No
15 March 2021
London MI Service

Lactation Safety Information

pegylated unglycosylated recombinant human granulocyte-colony stimulating factor

pegylated unglycosylated recombinant human granulocyte-colony stimulating factor
No direct published evidence of safety
Low levels anticipated in milk due to the drug's properties which are unlikley to be absorbed from the infants GI tract
G-CSF is a normal component of breast milk
16 September 2020

New Medicines

pegfilgrastim biosimilar (MSB11455) Chemotherapy-induced neutropenia

Information

pegfilgrastim biosimilar (MSB11455)
Biosimilar
Fresenius Kabi
Fresenius Kabi

Development and Regulatory status

Phase I Clinical Trials
Pre-registration (Filed)
Pre-registration (Filed)
May 20Filed in US. The submission was based on the results of two pivotal clinical trials that showed equivalent pharmacokinetic and pharmacodynamic profile to pegfilgrastim, as well as similar immunogenicity in healthy volunteers. The safety profile of the biosimilar was also comparable to pegfilgrastim [5].
May 20The EMA has accepted for review the company’s Marketing Authorization Application for MSB11455, a biosimilar pegfilgrastim [4].
Mar 19No development reported [2].

Category

Long acting analogue of filgrastim, colony stimulating factor
Neutropenia means a low neutrophil count. The normal range for neutrophils is 2.5-7.5 x 109/L. Moderate neutropenia is defined as neutrophil count of 0.5-1.0 x 109/L. Severe neutropenia is a count of <0.5 x 109/L.
Chemotherapy-induced neutropenia
Subcutaneous injection

Trial or other data

Oct 18MSB11455, met its primary endpoints in the two pivotal clinical studies comparing it with Neulasta; one was a pharmacokinetic and pharmacodynamics study and the other an immunogenicity and safety study [1].

Udenyca Neutropenia

Information

Udenyca
Biosimilar
Coherus Biosciences
Coherus Biosciences

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Feb 21Coherus continues to seek partners to help with commercialisation [12].
May 20Coherus Biosciences is seeking potential licensing partners for commercialising pegfilgrastim biosimilar in the European Union (NB dated 2016) [11].
Dec 18UK launch plans not yet available [10].
Nov 18Coherus announces planned launch date of Jan 2019 in the US, and a list price of $4,175, a 33% discount to Neulasta [9].
Nov 18Coherus BioSciences announced that the FDA has approved Udenyca [8].
Sep 18The EC has granted marketing authorization to Udenyca (formerly CHS-1701), a pegfilgrastim biosimilar [7].
Jul 18EU positive opinion for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) [6].
Jun 17FDA issues a complete response letter, which includes a request for reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients, which would have been a costlier delay. Coherus will work with the FDA to resolve the issues [5].
Nov 16EMA has accepted application for European licence, announced Coherus [4].
Jul 16Based on latest trial results, US filing now expected Q3 2016 [2]; company pipeline does not indicate any EU filing target for pegfilgrastim, although EU targets for adalimumab (2017) and etanercept (2016) biosimilars are shown [3].
Oct 15Coherus remains on track for its planned BLA filing in the first quarter of 2016 [1].

Category

Recombinant human granulocyte-colony stimulating factor
Neutropenia means a low neutrophil count. The normal range for neutrophils is 2.5-7.5 x 109/L. Moderate neutropenia is defined as neutrophil count of 0.5-1.0 x 109/L. Severe neutropenia is a count of <0.5 x 109/L.
Neutropenia
Subcutaneous injection

Trial or other data

Jul 16Coherus reports topline results from its follow-on study of CHS-1701, which met all its co-primary pharmacokinetic (Cmax and Area Under the Curve (AUC)) and pharmacodynamic endpoints (absolute neutrophil count (ANC), and ANCmax and ANC AUC). Based on these results, filing in the US is expected Q3 2016 [2].
Oct 15Results from PIII pharmacokinetic and pharmacodynamic (PK/PD) clinical study of CHS-1701 reported. This randomized, double-blind, single-dose, two-period crossover study in healthy subjects (n=116) assessed a single 6 mg SC injection of CHS-1701 vs. 6 mg SC dose of Neulasta in subjects randomized to Neulasta (Period 1) then CHS-1701 (Period 2) or CHS-1701 (Period 1) then Neulasta (Period 2). The primary PD endpoints of absolute neutrophil count (ANC) and PK parameters (bioequivalence for Cmax) were met. The AUC portion of the PK results are still under review [1]

Nyvepria Neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy

Information

Nyvepria
Biosimilar
Pfizer
Pfizer

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Approved (Licensed)
Mar 21Pfizer has no plans to launch this in the UK at this time [3].
Nov 20Approved in EU and UK to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes) [1,2].
Jun 20US FDA approves pegfilgrastim biosimilar (NYVEPRIATM) to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Also pre-registration in EU [2].
Jun 19Filed in the US [2].

Category

A PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analogue filgrastim.
Neutropenia means a low neutrophil count. The normal range for neutrophils is 2.5-7.5 x 109/L. Moderate neutropenia is defined as neutrophil count of 0.5-1.0 x 109/L. Severe neutropenia is a count of <0.5 x 109/L.
Neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy
Subcutaneous injection

Trial or other data

Oct 17Hospira completes a PI/II ascending dose study that assessed the pharmacodynamics, pharmacokinetics and safety of single and multiple doses of pegfilgrastim biosimilar (3mg and 6mg) SC injection for the prevention of febrile neutropenia in patients with non-metastatic breast cancer (NCT02650193). The trial characterised the pharmacodynamic response of absolute neutrophil count and CD34+ count (Cycle 0) and duration of severe neutropenia (Cycle 1) to the product. The open-label trial enrolled 48 patients in Hungary and Spain [2].

Evidence based evaluations

CegfilaNeutropenia

Information

Cegfila
Biosimilar
Mundipharma Int
Mundipharma Int

Development and Regulatory status

Licensed but not launched
Approved (Licensed)
Phase III Clinical Trials
Apr 20There are no current plans to launch Cegfila in the UK [4].
Dec 19Approved in EU [3].
Oct 19EU positive opinion for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) [1].

Category

Recombinant human granulocyte-colony stimulating factor
Neutropenia means a low neutrophil count. The normal range for neutrophils is 2.5-7.5 x 109/L. Moderate neutropenia is defined as neutrophil count of 0.5-1.0 x 109/L. Severe neutropenia is a count of <0.5 x 109/L.
Neutropenia
Subcutaneous injection

Evidence based evaluations