Cambridge company will assume responsibility for the promotion of biosimilar Herzuma▼® indicated for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer where tumours have either HER2 overexpression or HER2 gene amplification
Cambridge, UK: 19 March 2018 – Napp Pharmaceuticals Ltd today strengthened its partnership with biopharmaceutical company Celltrion Healthcare Hungary Kft, by securing exclusive UK distribution rights to its trastuzumab biosimilar. This will be the third biosimilar in Napp’s portfolio and also the third product it has partnered with Celltrion Healthcare on.
Paul Clark, Director of the Biosimilar Business Unit at Napp commented, “Having brought the first large molecule biosimilar to the UK in 2015, we are proud to further contribute to the UK’s growing biosimilar market with the trastuzumab biosimilar, Herzuma®. As a partnership selling organisation, we place relationships at the heart of what we do. This is evident both with our continued partnership with Celltrion Healthcare, as well as our collaboration with the NHS to help bring value-added medicines to patients in the UK.
Celltrion Healthcare’s decision to entrust us with a third biosimilar from their portfolio is testament to the insight and experience we’ve developed from successfully launching two previous monoclonal antibody biosimilars and we are excited to use our deep biosimilar expertise to bring Herzuma® to the UK market.”
Herzuma®, which is a biosimilar of the reference biologic, intravenous (IV) Herceptin®, was granted marketing authorisation on 9th February 2018 following positive opinion and recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2017  for HER2-positive early breast cancer in the neo‑adjuvant and adjuvant setting, metastatic breast cancer, and metastatic gastric cancer in adults . Breast cancer remains the most prevalent form of cancer in the UK, accounting for 15% of all new cancer cases, equating to around 54,900 cases per year, and one in eight women will be diagnosed with breast cancer during their lifetime . In 2014, breast cancer caused approximately 11,400 deaths in the UK and 78% of women in England and Wales survived the disease for 10 years or more . Around 15-20% of primary breast cancers are HER2-positive, which can be more aggressive than other types of breast cancer, as the higher than normal level of HER2 protein stimulates cancer cell growth .
Trastuzumab is recommended by European guidelines throughout the treatment pathway for HER2-positive breast cancer due to clinical benefit shown in a number of studies [5,6]. Gastric cancer led to around 4,500 deaths across the UK in 2014 . Studies have found that a range of 4.4% to 53.4%, with a mean of 17.9% of such cancers, show increased levels of HER2 .
“Biosimilars are an excellent opportunity to have high quality, lower cost drug options that improve the sustainability of cancer treatment in the UK” said Prof Andrew Wardley, Consultant Medical Oncologist, The Christie Hospital. “The launch of biosimilar trastuzumab means this important life-saving treatment will now be more affordable for the NHS”.
Currently, six out of the top ten medicines prescribed in NHS England hospitals are biological products . Biosimilars are typically much cheaper than the originator products and also provide a competitor product, which enables the NHS to potentially realise cost savings of at least £200-300 million per year by 2020/21, if the NHS embraces the use of best value biological medicines in a proactive, systematic and safe way . The NHS has already benefitted from significant savings on biological medicines since 2015, with savings of £160 million annually since the introduction of infliximab and etanercept biosimilars .
Man Hoon Kim, President and CEO of Celltrion Healthcare commented, “We are pleased to be partnering once again with Napp Pharmaceuticals Ltd on the commercialisation of our trastuzumab biosimilar. They have a proven track record of launching biosimilars in the UK, working effectively with many stakeholders across the NHS and demonstrating local in-market expertise. This alliance enables us to continue to pursue our commitment to delivering effective and affordable medicines which benefit healthcare systems, healthcare professionals and patients.”
HERZUMA® is a registered trade mark of Celltrion Healthcare, Inc. and is used under license.
HERCEPTIN® is a trade mark of Genentech, Inc.
Notes to editors:
Biosimilar is a term used to describe officially approved subsequent versions of biopharmaceutical medicines that are made available by a different company following patent and exclusivity expiry on the original product. Biosimilars are classed as biologic medical products, which mean they contain an active drug substance that is comprised of, or derived from, a living organism. Biosimilars are strictly regulated and need to demonstrate comparability to the previously approved reference product via a thorough development programme including quality, non-clinical and clinical data.
Trastuzumab is a monoclonal antibody designed to target the HER2 receptor. When it binds to the receptor, trastuzumab reduces HER2 signalling, that otherwise increases tumour stimulation, and also enables the immune system to target the cancerous tumour . It is administered on its own as monotherapy, as well as in combination with or following standard chemotherapy. Trastuzumab has changed the prognosis of patients with HER2-positive breast cancer, both in advanced and early stage disease .
About Napp Pharmaceuticals Limited
Napp Pharmaceuticals Limited is a UK pharmaceutical company based in the heart of the Cambridge science community, and part of a worldwide network of independently associated companies across 48 countries. Napp has grown up with the NHS, providing innovative medicines to patients in the UK since the 1920s. Napp is committed to improving patient outcomes and ensuring the sustainability of healthcare. At Napp, we are proud of our heritage, which began in the treatment of chronic pain and has expanded into respiratory medicine, diabetes, oncology and inflammatory disorders.
For more information, please visit: www.napp.co.uk
For further information, please contact: Hanna Wikström, Communications Lead / Napp Pharmaceuticals Ltd / firstname.lastname@example.org / T: +44 (0)1223 424 444
 European Medicines Agency – Committee for Medicinal Products for Human Use. Summary of opinion (initial authorisation) – Herzuma (trastuzumab). 14th December 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002575/WC500240426.pdf Accessed December 2017
 Herzuma (trastuzumab) powder for concentrate for solution for infusion. Summary of Product Characteristics. March 2018
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 NHS England (2017). Commissioning framework for biological medicines (including biosimilar medicines). https://www.england.nhs.uk/wp-content/uploads/2017/09/biosimilar-medicines-commissioning-framework.pdf Accessed March 2018
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