TRAZIMERA, a potential biosimilar to Herceptin® (trastuzumab), is Pfizer’s first therapeutic oncology biosimilar to undergo regulatory review in Europe
NEW YORK, NY, USA I June 01, 2018 I Pfizer Inc. (NYSE:PFE) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for TRAZIMERA™, a potential biosimilar to Herceptin® (trastuzumab), for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.1
”Pfizer is extremely proud to offer expanded biologic treatment options for patients by bringing more affordable, life changing biosimilar medicines to market, and today’s positive recommendation from the CHMP marks one more step forward. TRAZIMERA has the potential to help many patients with HER2 overexpressing cancers across Europe and, if approved, would help address the evolving needs of healthcare systems, physicians, payers and patients, “said Amrit Ray, MD, MBA, Global President, Research & Development, Pfizer Essential Health.
The regulatory submission is supported with a comprehensive data package and totality of evidence demonstrating a high degree of similarity to the originator product. This includes results from the primary REFLECTIONS B327-02 clinical comparative study, which demonstrated clinical equivalence and found no clinically meaningful differences between TRAZIMERA and Herceptin in patients with first line HER2 overexpressing metastatic breast cancer. As part of the REFLECTIONS clinical trial program for the proposed biosimilar trastuzumab, TRAZIMERA has been studied in nearly 500 patients and across more than 20 countries to date.2,3,4
“Many patients with breast and gastric cancers have an HER2 overexpression, which can correlate with poor outcomes and aggressive disease,” said Dr. Mark Pegram, associate director for clinical research at the Stanford Comprehensive Cancer Institute, and director of the Breast Oncology Program at the Stanford Women’s Cancer Center.5,6 “With the availability of biosimilars like TRAZIMERA in Europe, oncologists will have additional treatment options to choose from, which potentially helps our patients have greater access to these medicines.”
TRAZIMERA is Pfizer’s fourth7,8,9 biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA. Pfizer’s biosimilars pipeline is progressing and consists of 11 distinct Pfizer and legacy Hospira biosimilar molecules in various stages of development.
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. Herceptin Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf. Accessed November 2017.
2 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.
3 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
4 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.
5 Macmillan. HER2 positive breast cancer. Available at https://www.macmillan.org.uk/cancerinformation/cancertypes/breast/aboutbreastcancer/typesandrelatedconditions/her2%20positive.aspx
6 Iqbal N, 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_PipelineUpdate.pdf.
7 European Medicines Agency. European public assessment report (EPAR) for RETACRIT. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000872/human_med_001031.jsp&mid=WC0b01ac058001d124 Accessed May 2018.
8 European Medicines Agency. European public assessment report (EPAR) for INFLECTRA. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002778/human_med_001677.jsp&mid=WC0b01ac058001d124 Accessed May 2018.
9 European Medicines Agency. European public assessment report (EPAR) for NIVESTIM. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001142/human_med_001344.jsp&mid=WC0b01ac058001d124
SOURCE: Pfizer
Post Views: 17
TRAZIMERA, a potential biosimilar to Herceptin® (trastuzumab), is Pfizer’s first therapeutic oncology biosimilar to undergo regulatory review in Europe
NEW YORK, NY, USA I June 01, 2018 I Pfizer Inc. (NYSE:PFE) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for TRAZIMERA™, a potential biosimilar to Herceptin® (trastuzumab), for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.1
”Pfizer is extremely proud to offer expanded biologic treatment options for patients by bringing more affordable, life changing biosimilar medicines to market, and today’s positive recommendation from the CHMP marks one more step forward. TRAZIMERA has the potential to help many patients with HER2 overexpressing cancers across Europe and, if approved, would help address the evolving needs of healthcare systems, physicians, payers and patients, “said Amrit Ray, MD, MBA, Global President, Research & Development, Pfizer Essential Health.
The regulatory submission is supported with a comprehensive data package and totality of evidence demonstrating a high degree of similarity to the originator product. This includes results from the primary REFLECTIONS B327-02 clinical comparative study, which demonstrated clinical equivalence and found no clinically meaningful differences between TRAZIMERA and Herceptin in patients with first line HER2 overexpressing metastatic breast cancer. As part of the REFLECTIONS clinical trial program for the proposed biosimilar trastuzumab, TRAZIMERA has been studied in nearly 500 patients and across more than 20 countries to date.2,3,4
“Many patients with breast and gastric cancers have an HER2 overexpression, which can correlate with poor outcomes and aggressive disease,” said Dr. Mark Pegram, associate director for clinical research at the Stanford Comprehensive Cancer Institute, and director of the Breast Oncology Program at the Stanford Women’s Cancer Center.5,6 “With the availability of biosimilars like TRAZIMERA in Europe, oncologists will have additional treatment options to choose from, which potentially helps our patients have greater access to these medicines.”
TRAZIMERA is Pfizer’s fourth7,8,9 biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA. Pfizer’s biosimilars pipeline is progressing and consists of 11 distinct Pfizer and legacy Hospira biosimilar molecules in various stages of development.
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. Herceptin Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf. Accessed November 2017.
2 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.
3 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
4 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.
5 Macmillan. HER2 positive breast cancer. Available at https://www.macmillan.org.uk/cancerinformation/cancertypes/breast/aboutbreastcancer/typesandrelatedconditions/her2%20positive.aspx
6 Iqbal N, 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_PipelineUpdate.pdf.
7 European Medicines Agency. European public assessment report (EPAR) for RETACRIT. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000872/human_med_001031.jsp&mid=WC0b01ac058001d124 Accessed May 2018.
8 European Medicines Agency. European public assessment report (EPAR) for INFLECTRA. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002778/human_med_001677.jsp&mid=WC0b01ac058001d124 Accessed May 2018.
9 European Medicines Agency. European public assessment report (EPAR) for NIVESTIM. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001142/human_med_001344.jsp&mid=WC0b01ac058001d124
SOURCE: Pfizer
Post Views: 17
