The European Commission decision marks the approval of Pfizer’s first therapeutic oncology biosimilar
July 31, 2018 I Pfizer Inc. (NYSE: PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin® (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal Products for Human Use in May 2018.1
“TRAZIMERA has the potential to help many patients with HER2 overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease,” 3,4 said Professor Diana Lüftner, Charité Campus Benjamin Franklin and Member of the Presidency of the German Society of Hematology and Medical Oncology. “Today’s approval will help enable greater access for patients and physicians across Europe, without compromising on quality, efficacy and safety.”
Richard Blackburn, Global President, Pfizer Essential Health Europe, Africa/Middle East and Biosimilars said “The approval of TRAZIMERA, Pfizer’s first oncology biosimilar, is another significant step in our quest to introduce more treatment options for patients in Europe. Pfizer is investing in developing and launching a range of biosimilars which can help to reduce healthcare costs and increase patient access to important medicines.”
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*Herceptin® is a registered trademark of Genentech – A Member Of The Roche Group
The EC approval is based on a comprehensive submission package which demonstrated a high degree of similarity for TRAZIMERA and the originator product. The data included results from the REFLECTIONS B327-02 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between TRAZIMERA and originator product in patients with first line HER2 overexpressing metastatic breast cancer.5,6,7
TRAZIMERA is Pfizer’s fourth 8,9,10 biosimilar, and the first oncology biosimilar, to receive European approval. Pfizer’s biosimilars pipeline consists of 9 distinct Pfizer and legacy Hospira biosimilar molecules in various stages of development.
About TRAZIMERA (trastuzumab biosimilar
TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow.11 It locks on to the HER2 protein and blocks the receptor, stopping cell division and growth. 11
TRAZIMERA has been studied in nearly 500 patients and across more than 20 countries to date as part of the REFLECTIONS studies.5,6,7, 12,13
Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
1 European Medicines Agency. Trazimera. Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_… Accessed July 2018
2 European Medicines Agency. Herceptin Summary of Product Characteristics. Available at
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Info… Accessed June 2018
3 Macmillan. HER2 positive breast cancer. Available at https://www.macmillan.org.uk/cancerinformation/cancertypes/breast/aboutb… Accessed June 2018
4 Iqbal N. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014. 10.1155/2014/852748.
Pfizer. (2018, January 30). Pfizer pipeline. Retrieved from https://www.pfizer.com/sites/default/files/product-pipeline/01302018_Pip…. Accessed June 2018
5 Pegram M, Tan-Chiu E, Freyman A, et al. Abstract 238PD. A randomized, double-blind study of PF 05280014 (a potential trastuzumab biosimilar) vs trastuzumab, both in combination with paclitaxel, as first-line treatment for HER2-positive metastatic breast cancer. Presented at ESMO 2017.
6 Lammers PE, Dank M, Masetti R, et al. A randomized, double-blind study of PF 05280014 (a potential biosimilar) vs trastuzumab, both given with docetaxel (D) and carboplatin (C), as neoadjuvant treatment for operable human epidermal growth factor receptor 2-positive (HER2+) breast cancer. Abstract 154PD. Presented at ESMO 2017
7 Yin D, Barker K B, Li R, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). BR J Clin Pharmacol. 2014. 78(6): 1281-90.
8 European Medicines Agency. European public assessment report (EPAR) for RETACRIT. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici… Accessed June 2018.
9 European Medicines Agency. European public assessment report (EPAR) for INFLECTRA. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici… Accessed June 2018.
10 European Medicines Agency. European public assessment report (EPAR) for NIVESTIM. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici… Accessed June 2018
11 Macmillan Cancer Support. Trastuzumab. (Herceptin) Available at https://www.macmillan.org.uk/cancerinformation/cancertreatment/treatment… Accessed June 2018
12 Clinicaltrials.gov. NCT01989676. A study of PF-05280014 [trastuzumab-Pfizer] or Herceptin (trastuzumab) plus paclitaxel in HER2 positive first line metastatic breast cancer treatment (REFLECTIONS B327-02). Available at https://clinicaltrials.gov/ct2/show/NCT01989676?term=NCT01989676&rank=1. Accessed June 2018
13 Clinicaltrials.gov. NCT02187744. A study of PF-05280014 or trastuzumab plus taxotere and carboplatin in HER2 positive breast cancer in the neoadjuvant setting (REFLECTIONS B327-04). Available at https://clinicaltrials.gov/ct2/show/NCT02187744?term=NCT02187744&rank=1. Accessed June 2018
SOURCE: Pfizer
