Napp Launches Pelmeg (Biosimilar Pegfilgrastim) In The UK

Napp Pharmaceuticals Limited recently announced the UK launch of Pelmeg, a biosimilar of pegfilgrastim, following European Commission (EC) approval in November 2018¹. Pelmeg is indicated for the reduction in the duration of neutropenia and incidence of febrile neutropenia (FN) in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)². This is Napp’s first launch of a product developed by Cinfa Biotech, which was acquired by the Mundipharma network of independent associated companies in October 2018³.

Pelmeg is a self-administered, single dose formulation and a lower drug cost alternative to the existing long-acting option Neulasta ^2,4,5 Longer-acting alternatives can offer a less demanding treatment schedule for patients between chemotherapy cycles. The current standard of care requires daily injection ^2,6.

Although there have been improvements in the prognosis of FN, it is still responsible for considerable morbidity and mortality, with 20%-30% of patients requiring costly in hospital management and an overall mortality rate of approximately 10%.⁷ People who experience neutropenia and FN are at higher risk of infection, treatment dose reductions and dose delays.⁸ Failure to deliver planned chemotherapy can therefore be a major consequence of FN, that should be prevented as a clinical priority.⁹

Biosimilar medicines are playing an increasingly important role in the oncology treatment pathway within the UK health system. Pelmeg offers a patient centric, effective alternative treatment option at a vital point in cancer care that can help address both the resource pressures on the health system, as well as patient needs.

Paul Clark, Director of Biosimilars at Napp Pharmaceuticals Ltd said “We are proud to be delivering treatments that address patient need in the oncology treatment pathway and that could potentially improve patient experience at such a critical time. We hope that Pelmeg will not only help to alleviate some of the resource pressures on the NHS by providing a more affordable long-acting treatment option, but that it may also help improve patient access to these vital medicines.”

About Pelmeg
Pelmeg is a pegfilgrastim biosimilar.¹⁰ 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 duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).² It is administered as a subcutaneous injection once per chemotherapy cycle, at least 24 hours after cytotoxic chemotherapy.²

The approval of Pelmeg was based on a robust regulatory submission of rigorous analytical, biofunctional, preclinical and clinical studies to demonstrate biosimilarity in terms of its quality, safety and efficacy profile compared with the reference pegfilgrastim.¹⁰ As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe) Neulasta.¹¹

About neutropenia and febrile neutropenia
People being treated with 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.¹² FN is a low level of neutrophils in the blood accompanied by a fever.¹² People with FN caused by chemotherapy treatment for cancer are at increased risk of severe infection and death.¹²

About Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited is a UK pharmaceutical company established in the 1920’s and based in the heart of the Cambridge science community. Focused principally in the areas of diabetes, respiratory, cancer, arthritis and gastroenterology, we have worked side by side with the NHS since its inception. As the UK healthcare environment has evolved, so has Napp, ensuring we have the right expertise to mirror what the NHS needs from us, understanding NHS priorities and what influences and drives decision-making.

We are part of a worldwide network of independent companies, which gives us the flexibility to make locally driven decisions quickly. We have developed our working practices to ensure we can be agile, and act fast and efficiently, in order to help our partners, deliver sustainable healthcare solutions that ultimately improve patient outcomes. We aim to bring value-added medicines to the NHS by building effective partnerships. This is innate in the way we work because we are a partnership-based organisation, placing it at the heart of everything we do and every relationship, from our wholesale distributors to NHS deci­sion-makers.

We are extremely proud of our heritage in partnership working, which is centred around building and developing mutually beneficial, enduring partnerships that are open and based on respect – this is how we have built our reputation as a partner of choice. For more information, visit www.napp.co.uk

References
^[1]European Medicines Agency. Pelmeg (pegfilgrastim) European Public Assessment Report. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg#overview-section . Last accessed February 2019.

^[2] EMC. Pelmeg 6mg solution for injection pre-filled syringe. Available at: https://www.medicines.org.uk/emc/product/9849/smpc. Last accessed: February 2019.

^[3] Pharmaphorum. Mundipharma buys Spanish biosimilars firm Cinfa Biotech. Available at: https://pharmaphorum.com/news/mundipharma-buys-spanish-biosimilars-firm-cinfa-biotech/. Last accessed February 2019.

^[4] EMC. Pelmeg 6 mg solution for injection in pre-filled syringe. Package leaflet: Information for the user. Available at: https://www.medicines.org.uk/emc/files/pil.9849.pdf. Last accessed February 2019.

^[5] MIMS online. Pelmeg. Available at: www.mims.co.uk. Last accessed February 2019.

^[6] EMC Neupogen Singleject 30 MU (0.6 mg/ml). Available at: https://www.medicines.org.uk/emc/product/608/smpc. Last accessed: February 2019.

^[7] Klastersky J, de Naurois J, Rolston K, et al. Management of febrile neutropaenia: ESMO Clinical Practice Guidelines. Ann Oncol. 2016;27(Suppl 5):v111–v118.

^[8]Crawford J, Dale DC, Lymann GH. Chemotherapy-Induced Neutropenia. Risks, Consequences, and New Directions for Its Management Cancer 2004;100(2):228–37.

^[9] Aapro et al. 2010. Prophylaxis of chemotherapy-induced febrile neutropenia with granulocyte colony-stimulating factors: where are we now? Support Care Cancer. 2010 May; 18(5): 529–541.

^[10] European Medicines Agency. Pelmeg (pegfilgrastim) European Public Assessment Report. Available at: https://www.ema.europa.eu/documents/assessment-report/pelmeg-epar-public-assessment-report_en.pdf. Last accessed February 2019.

^[11] EMC Nuelasta. Available at: https://www.medicines.org.uk/emc/product/6770/smpc. Last accessed February 2019.

^[12] Patel et al. 2017. Febrile Neutropenia. JAMA Oncol. 2017;3(12):1751. doi:10.1001/jamaoncol.2017.1114