European Commission approves Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with chemotherapy


Pelmeg is a pegfilgrastim biosimilar that is delivered subcutaneously 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 leukaemia and myelodysplastic syndromes)
1
 Pelmeg has been through rigorous analytical, biofunctional, preclinical and clinical studies to demonstrate
biosimilarity in terms of its quality, safety and efficacy profile compared with the reference pegfilgrastim2
 Pelmeg was developed by Cinfa Biotech, now part of the Mundipharma network of independent associated
companies
CAMBRIDGE, UKhe Mundipharma network of independent associated companies
today announced that the European Commission (EC) has granted approval for the use of Pelmeg®
(pegfilgrastim) as a treatment 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
The EC’s decision follows a recommendation from the Committee for Medicinal Products for Human Use
(CHMP) that was based on a robust regulatory submission of key biosimilarity data from analytical,
biofunctional and clinical study comparisons for Pelmeg.
2
In all cases it demonstrated comparable
pharmacodynamics, pharmacokinetics, and immunogenicity to its reference product Neulasta.
3,4,5 The
information submitted, and conclusions reached, were comprehensive enough to extrapolate the indication for
Neulasta across to Pelmeg.
2 As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe)
Neulasta.
“We hope this approval will significantly improve the lives of people who are affected by chemotherapy
induced neutropenia and febrile neutropenia. The availability of this biosimilar represents an important
opportunity to reduce healthcare costs while increasing access to an effective treatment option,” said Philippe
Bastide, Head of Biosimilars, Mundipharma International.
Pelmeg is the fourth biosimilar medicine to be commercialised by the Mundipharma network. It was developed
by Cinfa Biotech which was acquired by the Mundipharma network and announced in October 2018. The
acquisition of Cinfa Biotech provides Mundipharma with global reach and expanded development capabilities.
#ENDS#
Prepared November 2018
MINT/PELM 18006c
FOR EU MEDICAL MEDIA ONLY
▼ This medicinal product is subject to additional monitoring.
Notes to editors
About the clinical data
A comprehensive analytical, biofunctional, preclinical and clinical comparability programme has demonstrated a
high degree of similarity between Pelmeg and Neulasta. Its biosimilarity has been studied in healthy volunteers
who have no comorbidities, require no co-medication and are immunocompetent.
3,4,5
The Pelmeg data:
 Confirmed biosimilarity to Neulasta in sensitive clinical study settings
 Demonstrated pharmacokinetic comparability to Neulasta at the clinical dose of 6 mg
 Demonstrated pharmacodynamic comparability to Neulasta at the clinical dose of 6 mg and at the
reduced dose of 3 mg
 Did not show any clinically meaningful differences in the safety and immunogenicity profile
compared to Neulasta
About Pelmeg®
Pelmeg is a pegfilgrastim biosimilar.6
Pegfilgrastim is a pegylated version of granulocyte-colony stimulating factor
(G-CSF) that works by stimulating the bone marrow to produce more neutrophils, thereby reducing the
incidence of febrile neutropenia. It is administered as a subcutaneous injection once per chemotherapy cycle, at
least 24 hours after cytotoxic chemotherapy.
6
About neutropenia and febrile neutropenia
People taking chemotherapy for cancer are at risk of dangerously low levels of a type of white blood cell called
a neutrophil. Neutrophils play an important role in the immune system guarding against infection. Febrile
neutropenia is a low level of neutrophils in the blood accompanied by a fever.7
About the Mundipharma network
The Mundipharma network of independent associated companies has distribution and marketing rights from
Celltrion Healthcare for three prior biosimilars – Remsima®
, Truxima®
and Herzuma®
– in Germany,
Luxembourg, Ireland (Truxima®
and Herzuma® only), Italy, UK, Netherlands and Belgium.
The Mundipharma global network of privately-owned independent associated companies was founded in 1956
by doctors and now operates in over 120 countries worldwide. We are focused on developing business
partnerships to identify and accelerate meaningful technology across an increasingly diverse portfolio of
therapy areas including respiratory, oncology, pain, and biosimilars. Consistent with our entrepreneurial
heritage, we like to think we see what others don’t by challenging conventional wisdom and asking different
and challenging questions. By working in partnership with all our stakeholders, the Mundipharma network
develops medicines that create value for patients, payers and wider healthcare systems.
Prepared November 2018
MINT/PELM 18006c
FOR EU MEDICAL MEDIA ONLY
Neulasta®
is a registered trademark of Amgen, Inc.
Pelmeg®
is a registered trademark of Cinfa Biotech, S.L.
Herzuma®
, Truxima®
and Remsima®
are all registered trademarks of Celltrion Inc. and are used under license.
For further information please contact:
Alison Dyson, Communications Lead
Telephone: +44 (0) 1223 397346
Email: alison.dyson@mundipharma.com
Or email: communications@mundipharma.com
References
1 EMA decision. Available online at: http://ec.europa.eu/health/documents/community-register/html/register.htm. Last
accessed November 2018
2 European Medicines Agency. Pelmeg® (pegfilgrastim) Summary of opinion (initial authorisation). September 2018.
Available at: https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-pelmeg_en.pdf. Last
accessed November 2018
3 Roth K et al. Demonstration of pharmacokinetic and pharmacodynamic comparability in healthy volunteers for B12019, a
proposed pegfilgrastim biosimilar. Abstract 241. Presented at the European Cancer Congress (ECCO), 27–30 January
2017, Amsterdam, The Netherlands.
4 Roth K et al. Comparability of pharmacodynamics and immunogenicity of B12019, a proposed pegfilgrastim biosimilar to
Neulasta®. Abstract 1002. Presented at the 59th American Society of Hematology (ASH) Annual Meeting, 9–12 December
2017, Atlanta, USA.
5 Roth K et al. Pharmacokinetic and pharmacodynamic comparability of B12019, a proposed pegfilgrastim biosimilar. Poster
1573. Presented at the European Society for Medical Oncology (ESMO), 8–12 September 2017, Madrid, Spain.
6 EMA website. SmPC Neulasta. Available online at: https://www.ema.europa.eu/documents/product-information/neulastaepar-product-information_en.pdf. Last accessed November 2018
7 Patel K & West H. JAMA Oncol. 2017;3(12):1751. doi:10.1001/jamaoncol.2017.1114

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post