Biologics have been used increasingly in the treatment and supportive care of cancer; however, their high cost places a significant burden on healthcare systems. The expiration of patents for biologics has led to the development of biosimilars, with the aim of reducing cost and increasing accessibility to novel treatments, which are affordable for a greater number of patients. Biosimilars are highly similar but not identical to the reference products; therefore, strict regulatory requirements have been formed for their approval. This ensures that there are no clinically meaningful differences compared with respective biologics, with regard to purity, safety and efficacy. In 2003, a regulatory framework for the approval of biosimilars was established in Europe, whereas the USA did not implement a framework until 2009, when the Biologics Price Competition and Innovation Act was formed. A number of biosimilars have currently been approved in oncology and the number is expected to rise in the near future. More than 10 years of evidence has revealed that biosimilars are safe and effective; however healthcare professionals need to be further educated to eliminate potential misconceptions and integrate biosimilars into routine clinical practice. The present review aims to provide an overview of the biosimilars used in Europe and the USA, present their main benefits and challenges, and discuss their current and future roles in medical oncology.

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Objectives: Treatment with cobimetinib (C) combined with vemurafenib (V) was used in France in 2015 through a 'Temporary Authorization for Use' program (TAU, pre-approval access) and it was marketed on January 2016 for adult patients (pts) with BRAF V600 mutation-positive (+) advanced melanoma. This study aimed to provide real-world effectiveness for a relevant time in pts previously registered in the C TAU. Methods: This non-interventional, ambispective, multicenter French study was conducted from 10/2016 to 08/2018 in pts with BRAF V600+ advanced melanoma, with an 18-month follow-up after inclusion. To search for factors associated with survival results (OS and PFS evaluated by Kaplan-Meier method), survival trees were grown on the analysed pts with all baseline covariates. Two control fixed parameters (a maximum depth of 3 successive splits and a minimum of 60 pts in each terminal node) were used in the analyses. Results: Mean age of the 185 evaluable pts was 57613 years; 63% were men. 159 pts (88%) had disease stage IV. Eastern Cooperative Oncology Group (ECOG) score was $2 in 10% of pts (11/114). Prior therapies included surgery (90%), radiation therapy (28%). Median C duration was 14.0 months (mo) (interquartile range: 5.8-18.7). Median OS was 16.1 mo ] and median PFS was 7.3 mo ]. Disease stage IV-M1c (or missing; n=118 pts) was shown to be associated with a shorter median OS, 9.3 mo. Identical groups of pts were shown for the factors associated to PFS: disease stage IV-M1c (or missing; n=118 pts) was shown to be associated with a shorter median PFS compared to other pts (n=67): 4.5 mo and 12.0 mo, respectively. Conclusions: Using survival decision trees, disease stage IV-M1c was shown to be the factor associated with shorter OS and PFS.

NSCLC diagnosis, who initiated systemic treatment between August 15th 2016 and August, 14th 2018. Result: A total of 472 patients were included in the registry. Demographic and first-line treatment information are presented in Table 1, along with the respective comparison between patients tested and not tested for PD-L1. Patients with ECOG PS 0-1 are more likely to be tested for PD-L1 status. Among patients tested for PD-L1, Dako 22C3 was the most commonly used testing assay (87.8%). The number of patients tested for PD-L1 increased between the two consecutive time periods (from August 15th 2016 to August, 14th 2018; Table 2).

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