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2018-08-08

Accord Healthcare’s Pelgraz® (pegfilgrastim) Given Positive Opinion by CHMP

Following marketing authorisation grant, Pelgraz, a pegylated G-CSF biosimilar, would be the latest addition to Accord Healthcare’s established portfolio of over 30 oncology treatments across Europe. Accord Healthcare will potentially be the first to launch a biosimilar pegfilgrastim across Europe.

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Accord’s Pelgraz (pegfilgrastim), a pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe1. Once approved, Pelgraz could be the first biosimilar pegfilgrastim to market in Europe intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy1. The World Health Organisation consider G-CSF essential therapies due to their impact on febrile neutropenia, chemotherapy dose delays, and dose density2.

Neutropenia is still one of the most common reasons for reductions or delays in the chemotherapy schedule which impairs survival outcomes and quality of life for patients. Evidence shows that daily G-CSFs are incorrectly administered in 42% of chemotherapy cycles, long acting pegfilgrastim has been shown to greatly reduce that figure to just 8%3.

Binish Chudgar, Vice Chairman and Managing Director of the Intas Group stated “Accord launched its first European approved biosimilar product, Accofil (filgrastim), in 2015 and despite being the 6th entrant has become a leading supplier of this important medicine. Since then the product has been used over 2 million times and Accord has gained valuable experience in bringing biosimilar medicines to market. Our continued focus on bringing biopharmaceuticals to Europe has enabled us to potentially be first to launch a biosimilar pegfilgrastim, and as a potential first mover we expect to gain an even bigger market share with Pelgraz.”

Accord will manufacture this medicine in its own state of the art production facility. The company has deep experience with biosimilar medicines and as of 2017 were assessed using IQVIA data to have the second highest number of biosimilars in phase III to approval in the world4. This reflects the strategy of a long-standing commitment in biopharmaceutical development, research and manufacturing.

The CHMP positive opinion was based on Pelgraz’s substantial clinical development programme, which supported its biosimilarity with the reference product Neulasta® (pegfilgrastim)1.

Paul Tredwell, Accord VP Speciality Brands, EMENA said “At Accord, our mandate is to deliver affordable medicines that make a real difference to patients’ lives. With approval and commercialisation, we hope to provide patients with the first pegylated biosimilar of pegfilgrastim that will reduce the strain on healthcare providers’ budget, while potentially improving the standard of care and associated outcomes for patients.”

Tredwell concluded “Accord is providing affordable alternatives in some of the most complex areas of medicine and this medicine reflects our increased focus in speciality pharmaceuticals (including oncology, critical care, auto-immune, fertility and central nervous system conditions.) We already have an established footprint across 93% of European countries directly serving the European population with over 30 oncology therapies via our own commercial infrastructure, and this latest recommendation further underlines our commitment to oncology patients.”

References

1 EMA CHMP Summary of Opinion
2 WHO Technical Report Series “The Selection and Use of Essential Medicines”
3 Lambertini M et al. (2015). Pegfilgrastim for the prevention of chemotherapy-induced febrile neutropenia in patients with solid tumors. Expert opinion on biological therapy. 15. 1-19.
4 IQVIA “Trends in the development of the Biosimilar market” March 2018

                                                                                                                 
Date of preparation August 2018. UK&IE/PEG/0004/07-18

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