Trastuzumab Biosimilars in the Therapy of Breast Cancer - "Real World" Experiences from four Bavarian University Breast Centres.

Introduction With the introduction of the first trastuzumab biosimilar in the summer of 2018, biosimilar antibodies for breast cancer have found their way into the area of gynaecological oncology. The switch of anti-human epidermal growth factor receptor 2 (HER2) therapy from the reference drug Herceptin ^® to a biosimilar has presented challenges to the clinics. In addition to structural and organisational measures, training of employees as well as patient briefing and acceptance were major challenges. The study presented here records - within the context of quality assurance - how the switch to a trastuzumab biosimilar was implemented at four Bavarian university clinics in the Purchasing Association of Bavarian University Pharmacies. Materials/Methods Questionnaires on treatment figures and the switching process were sent to breast centres and pharmacies of four Bavarian university clinics between July and December 2019. The neoadjuvant, adjuvant and metastasised anti-HER2 therapy with trastuzumab with or without pertuzumab was recorded, evaluated and summarised. Results In the anti-HER2-therapy, trastuzumab was used intravenously (i. v.) and subcutaneously. Between July and December 2018, all four clinics in the Purchasing Association switched the i. v. trastuzumab therapy from the reference drug (Herceptin) to a biosimilar (for 2018: Kanjinti ^® ). Over 200 patients were treated with trastuzumab i. v. in each of the two half-years of 2018 (before and after the switch). The spectrum of side effects and pCR rates under therapy with the biosimilar were comparable to the experiences made with the reference drug. Three out of four clinics provided training to employees and informed patients by means of a defined information leaflet. Patient acceptance was high. Summary The anti-HER2 therapy could be switched successfully and safely to trastuzumab biosimilars at the Bavarian university hospitals. This may serve as guideline for the further implementation of biosimilars. The structures necessary for this initial switching process have been prepared with trastuzumab as an example.
Competing Interests: Conflict of Interest/Interessenkonflikt Anna Hester received honoraria for lectures and advisory boards from Roche as well as honoraria for lectures and reimbursement of training costs from Pfizer. Peter A. Fasching received research support from Novartis and BioNTech and honoraria from Novartis, Roche, Pfizer, Celgene, Daiichi-Sankyo, Teva, AstraZeneca, Puma, Eisai, Merck Sharp & Dohme, MSD and Myelo Therapeutics. Johannes Ettl received honoraria for consultancy work from Eli Lilly, Novartis, Pfizer Inc, AstraZeneca and Roche as well as honoraria and travel support from Celgene, Eli Lilly, Novartis, Pfizer Inc, Roche, Teva, AstraZeneca and Tesaro. Anne Katrin Krämer received honoraria for advisory boards from Novartis, honoraria for lectures from Teva and reimbursement of training and travel expenses from Celgene, Novartis, IGEA and MSD. Achim Wöckel recieved honoraria for consultancy work, lectures and support for expert training from Amgen, AstraZeneca, Aurikamed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, Tesaro, Sirtex, MSD and Genomic Health. Nadia Harbeck recieved honoraria for lectures and/or consultancy work from Amgen, AstraZeneca, Celgene, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Samsung and Sandoz. Rachel Würstlein receved honoraria for consultancy work as well as support for travel expenses from Agendia, Amgen, Aristo, AstraZeneca, Boeringer Ingelheim, Carl Zeiss, Celgene, Clinsol, Daiichi-Sankyo, Eisai, Genomic Health, Glaxo Smith Kline, Hexal, Lilly, Medstrom Medical, MSD, Mundipharma, Nanostring, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, Teva. All other authors indicate that there are no conflicts of interest./ Anna Hester erhielt Honorare für Vorträge und Advisory Boards von Roche sowie Honorare für Vorträge und Erstattung von Fortbildungskosten von Pfizer. Peter A. Fasching erhielt Forschungsunterstützung von Novartis und BioNTech und Honorare von Novartis, Roche, Pfizer, Celgene, Daiichi-Sankyo, Teva, AstraZeneca, Puma, Eisai, Merck Sharp & Dohme, MSD und Myelo Therapeutics. Johannes Ettl erhielt Honorare für Beratertätigkeit von Eli Lilly, Novartis, Pfizer Inc, AstraZeneca und Roche sowie Honorare und Reisekostenunterstützung von Celgene, Eli Lilly, Novartis, Pfizer Inc, Roche, Teva, AstraZeneca und Tesaro. Anne Katrin Krämer erhielt Honorare für Advisory Boards von Novartis, Honorare für Vorträge von Teva und Erstattung von Fortbildungs- und Reisekosten von Celgene, Novartis, IGEA und MSD. Achim Wöckel erhielt Honorare für Beratung, Vorträge und Unterstützung von Fachfortbildungen von Amgen, AstraZeneca, Aurikamed, Celgene, Eisai, Lilly, Novartis, Pfizer, Roche, Tesaro, Sirtex, MSD und Genomic Health. Nadia Harbeck erhielt Honorare für Vorträge und/oder Beratungen von Amgen, AstraZeneca, Celgene, Lilly, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Samsung und Sandoz. Rachel Würstlein erhielt Honorare für Beratertätgkeit sowie Reisekostenunterstützung von Agendia, Amgen, Aristo, AstraZeneca, Boeringer Ingelheim, Carl Zeiss, Celgene, Clinsol, Daiichi-Sankyo, Eisai, Genomic Health, Glaxo Smith Kline, Hexal, Lilly, Medstrom Medical, MSD, Mundipharma, Nanostring, Novartis, Odonate, Paxman, Palleos, Pfizer, Pierre Fabre, Puma Biotechnology, Riemser, Roche, Sandoz/Hexal, Seattle Genetics, Tesaro Bio, Teva. Alle weiteren Autoren geben an, dass keine Interessenkonflikte bestehen.