PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer

(2018) Philip E. Lammers et al.   BRITISH JOURNAL OF CANCER

A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results

(2018) X. Pivot et al.   EUROPEAN JOURNAL OF CANCER

Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer

(2018) Xavier Pivot et al.   JOURNAL OF CLINICAL ONCOLOGY

Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial

(2018) Gunter von Minckwitz et al.   LANCET ONCOLOGY

Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)–Positive Metastatic Breast Cancer

(2017) Hope S. Rugo et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial

(2017) Justin Stebbing et al.   LANCET ONCOLOGY

NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives

(2017) Andrew D. Zelenetz et al.   Journal of the National Comprehensive Cancer Network

Pre-existing Antibody: Biotherapeutic Modality-Based Review

(2016) Boris Gorovits et al.   AAPS Journal

ESMO European Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in Europe

(2016) N. Cherny et al.   ANNALS OF ONCOLOGY

Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280014 and Trastuzumab (Herceptin®)

(2014) Susan Hurst et al.   BIODRUGS

Expert perspectives on biosimilar monoclonal antibodies in breast cancer

(2014) J. Cortés et al.   BREAST CANCER RESEARCH AND TREATMENT

A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01)

(2014) Donghua Yin et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

(2014) Sharon H. Giordano et al.   JOURNAL OF CLINICAL ONCOLOGY

World Medical Association Declaration of Helsinki

(2013)   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Adjuvant Trastuzumab in HER2-Positive Breast Cancer

(2011) Dennis Slamon et al.   NEW ENGLAND JOURNAL OF MEDICINE

Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial

(2010) Yung-Jue Bang et al.   LANCET