Die Entscheidung fr das Biosimilar Kanjinti wurde durch verschiedene Faktoren beeinflusst

Die Entscheidung fr das Biosimilar Kanjinti wurde durch verschiedene Faktoren beeinflusst. 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: JNJ-64619178 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 Cd248 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. strong class=”kwd-title” Key words: HER2, breast cancer, trastuzumab, biosimilar, pCR Introduction Biological drugs (biologics) have become increasingly important in medicinal therapy in recent years. Biologics are large and complex biologically active molecules, which are produced biotechnologically as drugs from living cells. Owing to their size and complexity, complete molecular-genetic characterisation of biologics is often not achievable 1 ,? 2 . As soon as patent protection for a biologic expires, the drug may also be produced and marketed by other pharmaceutical companies. These biologic-equivalents (biosimilars) are structurally similar to the original drug and produce an identical effect in the human body. Since the production of these complex molecules occurs in living cells, biosimilars are however, depending on the production process, not fully identical in structure to the reference product. Likewise, different batches of the same product my show a certain structural variability. This represents the difference between biosimilars and chemically-synthesised, easily characterised generics. For marketing authorisation for a biosimilar, proof is required of identical biological characteristics, identical efficacy and identical safety 1 JNJ-64619178 ,? 5 . The American and European regulatory authorities describe the marketing authorisation concept for biosimilars as Totality of Evidence: This represents the entirety of all analytical, preclinical and clinical studies necessary for the marketing authorisation of a biosimilar. The concept follows a stepwise approach: The essential first step lies in the functional and JNJ-64619178 analytical testing to demonstrate, at the molecular level, the similarity of the biosimilar to the reference drug. The preclinical testing may then be shortened in comparison to the marketing authorisation process for new drugs and focuses on potential uncertainties arising from the qualitative analyses. Phase I studies must demonstrate the equivalence with regard to pharmacodynamics and kinetics; Phase III data on safety in clinical use must be collected in at least one indication. Once all the evidence has been provided, marketing authorisation of the biosimilar may occur in this indication. If it is demonstrated that the mechanism of action of the biosimilar in an additional indication is the same as in the indication studied (and if the above-mentioned data on pharmacokinetics, immunogenicity, efficacy and safety are available) marketing authorisation for this additional indication may be granted. This is termed the concept of extrapolation 3 ,? 4 ,? 6 ,? 7 . The first authorised biosimilar in Europe was the somatotropin biosimilar Omnitrope ? in 2006. Biosimilars C for example, the active substance filgastrim C have been in use for years in oncology and gynaecology. Biosimilar monoclonal antibodies found their way into gynaecological oncology with the marketing authorisation and availability of the first trastuzumab biosimilar for the therapy of HER2-positive breast cancer on 02 May 2018 8 . Clinical equivalence to the reference product was demonstrated for the trastuzumab biosimilar Kanjinti in the neoadjuvant and adjuvant setting 9 , for Trazimera ? in the metastatic setting 10 and for Herzuma ? in the neoadjuvant setting 11 . The corresponding marketing authorisation was then granted for neoadjuvant, adjuvant and metastatic therapy of breast and stomach cancer. The costs for oncologic therapies increased by 41% between 2011 and 2015 12 JNJ-64619178 . Most recently, in 2018, costs for oncologic therapies further increased by 6% when compared to 2017 13 . Oncologics are among the active.