Mundipharma expands biosimilar portfolio with exclusive partnership deal

Mundipharma expands biosimilar portfolio with exclusive partnership deal across seven European countries for trastuzumab biosimilar, Herzuma®

  • Exclusive distribution and marketing rights granted in seven European countries including Germany, Italy and UK
  • Third biosimilar deal with Celltrion Healthcare cements Mundipharma’s leadership position in the biosimilar market and is testament to Mundipharma’s commercialization expertise
  • Biosimilars are projected to save stretched European healthcare systems between €11.8bn and €33.4bn between 2007 and 20201

The Mundipharma global network of independent associated companies today strengthened its partnership with biopharmaceutical company Celltrion Healthcare Hungary Kft, by securing exclusive distribution rights to its trastuzumab biosimilar, Herzuma®in seven EU markets including Germany, Italy and the UK.

Man Hoon Kim, President and CEO of Celltrion Healthcare commented, “We are pleased to be partnering once again with Mundipharma on the commercialization of our trastuzumab biosimilar. They have a proven track record of launching biosimilars in Europe, working effectively across multiple healthcare systems 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®, which is a biosimilar of the reference biologic i.v. 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 20172 for HER2-positive early breast cancer in the neo‑adjuvant and adjuvant setting, metastatic breast cancer, and metastatic gastric cancer in adults3.Breast cancer remains the most prevalent form of cancer in women in Europe, affecting an estimated 362,000 women and causing around 92,000 deaths in 2012, with a five-year prevalence of over 1.4 million4. 15–20% of primary breast cancers are HER2-positive5, which can be more aggressive than other types of breast cancer.

Trastuzumab is recommended by European guidelines throughout the treatment pathway for HER2-positive breast cancer due to clinical benefit shown in a number of studies6,7. Gastric cancer lead to around 58,000 annual deaths across Europe in 20128 and 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 HER29.

Richard Trollope, Commercial Head of Oncology and Biosimilars at Mundipharma commented, “We are delighted to strengthen our partnership with Celltrion Healthcare and add an important medicine to our already successful biosimilar commercial platform.

“Celltrion Healthcare’s decision to entrust us with a third biosimilar from their portfolio is testament to the insight and experience we have developed from successfully launching two previous monoclonal antibody biosimilars. With Remsima® (infliximab) we achieved market leading status in the majority of our markets, and we are already seeing strong market uptake with our newest biosimilar medicine Truxima® (rituximab) across those markets where we have distribution rights.

“We look forward to, once again, using our expertise in biosimilars to navigate the complex European environment and enable Herzuma® to help healthcare economies deliver better value to patients.”

References:

  1. Haustein R, et al. Saving money in the European healthcare systems with biosimilars. Generics and Biosimilars Initiative Journal 2012; 1: 120–126
  2. 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 March 2018
  3. Herzuma (trastutuzmab) Summary of Product Characteristics. Available at: https://ec.europa.eu/health/documents/community-register/2018/20180209139854/anx_139854_en.pdf - accessed March 2018
  4. World Health Organization – International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide. Breast cancers. Available at http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx, accessed January 2018
  5. Wolff AC, et al. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update. Journal of Clinical Oncology 2013; 31: 3997–4013
  6. Senkus E, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 2015; 26(Suppl 5): v8–v30
  7. Cardoso F, et al. 3rd ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 3). Annals of Oncology 2017; 28: 16–33
  8. World Health Organization – International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide. Stomach cancers. Available at http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx, accessed January 2018
  9. Abrahao-Machado LF & Scapulatempo-Neto C. HER2 testing in gastric cancer: An update. World Journal of Gastroenterology 2016 ;22: 4619–4625
  10. Gajria D, et al. HER2-amplified breast cancer: mechanisms of trastuzumab resistance and novel targeted therapies. Expert Rev Anticancer ther. 2011 Fe: 11 (2): 263-275
  11. Bartsch R, et al. Trastuzumab in the management of early and advanced stage breast cancer. Biologics. 2007. Ma; 1(1): 19-31.

 

HERZUMA® is a registered trade mark of Celltrion, Inc. and is used under license.



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