European Commission Approves Pegfilgrastim Biosimilar Pelmeg

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The European Commission has granted approval for the use of Pelmeg®, also known as B12019, (pegfilgrastim biosimilar) 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.[1]

The approved drug is a biosimilar medicinal product and highly similar to the reference product Neulasta® (pegfilgrastim; Amgen), which was authorized in the EU on August 22, 2002. Data show that Pelmeg has comparable quality, safety and efficacy to the reference drug.

Biosimilars
Biosimilars medicines such Pelmeg as are copies of biopharmaceutical products for which the patent protection has expired. These medicines offer the same quality, safety and efficacy as the reference drug, often at a more affordable price, thus providing access of biological therapies to more patients.

Following a stringent review process, ensuring equivalent quality, safety and efficacy as the reference product, biosimilars may be approved by regulatory authorities, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).


...this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia..


Granulocyte-colony stimulating factor
Neutrophils are – as the body’s first line of defense – important to fighting off infections, particularly those caused by bacteria. The usually make up about half to two-thirds of all white blood cells. But chemotherapy can cause myelosuppression and febrile neutropenia, an unacceptably low level of white blood cells. As a result, cancer patients being treated with cytotoxic chemotherapy, are at risk of dangerously low levels of neutrophil, causing febrile neutropenia accompanied by a fever, making them susceptible to infections and sepsis.

The recombinant form of G-CSF is used to accelerate recovery and reduce mortality from neutropenia after chemotherapy, allowing higher-intensity treatment regimens.

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.

Pegfilgrastim is administered as a subcutaneous injection once per chemotherapy cycle, at least 24 hours after chemotherapy.

Recommendation
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 to the European regulatory authorities, 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.

Reference
[1] EMA decision. Last accessed November 23, 2018
[2] European Medicines Agency. Pelmeg® (pegfilgrastim) Summary of opinion (initial authorisation). September 2018. Last accessed November 23, 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. Last accessed November 2018
[7] Patel K, West HJ Febrile Neutropenia. JAMA Oncol. 2017 Dec 1;3(12):1751. doi: 10.1001/jamaoncol.2017.1114.


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