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A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product. Biosimilarity to the reference product (RP) in terms of quality characteristics, such as physicochemical and biological properties, safety, and efficacy, based on a comprehensive comparability exercise needs to be established. SB2 (Flixabi® and Renflexis®) is a biosimilar to Remicade® (infliximab). The development of SB2 was performed in accordance with relevant guidelines of the International Conference on Harmonisation, the European Medicines Agency, and the United States Food and Drug Administration. To determine whether critical quality attributes meet quality standards, an extensive characterization test was performed with more than 80 lots of EU- and US-sourced RP. The physicochemical characterization study results revealed that SB2 was similar to the RP. Although a few differences in physicochemical attributes were observed, the evidence from the related literature, structure-activity relationship studies, and comparative biological assays showed that these differences were unlikely to be clinically meaningful. The biological characterization results showed that SB2 was similar to the RP in terms of tumor necrosis factor–α (TNF-α) binding and TNF-α neutralization activities as a main mode of action. SB2 was also similar in Fc-related biological activities including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, neonatal Fc receptor binding, C1q binding, and Fc gamma receptor binding activities. These analytical findings support that SB2 is similar to the RP and also provide confidence of biosimilarity in terms of clinical safety and efficacy.

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In medical ultrasound imaging, lateral resolution is limited when using a fixed transmit focusing. Various synthetic aperture (SA) techniques, in which two-way dynamic focusing is enabled by utilizing prebeamformed radio-frequency (RF) data have been proposed for improving the spatial resolution. However, SA methods were not extensively evaluated in terms of their clinical performance. In this paper, a phantom and an in vivo evaluation of the SA method with bidirectional pixel-based focusing (BiPBF) is presented in comparison with the conventional beamforming. The performance of the proposed SA-BiPBF was assessed with a blind study and the established breast imaging-reporting and data system (BI-RADS), in addition to measuring contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR). Prebeamformed RF data were acquired from a tissue mimicking phantom (Model 040, CIRS Inc., Norfolk, VA, USA) and from patients with breast lesions by using a commercial ultrasound scanning system with a linear array transducer equipped with a research package and parallel data acquisition system (SonixTouch, SonixDAQ, and L14-5/38, Ultrasonix Corp., Canada). In phantom and in vivo experiments, a default setting of a breast preset was applied (e.g., the center frequency of 10 MHz and acoustic output of MI = 0.66). In phantom experiment, the SA-BiPBF method showed higher CNR and SNR values compared to the conventional method (3.4 and 23.9 dB versus 3.1 and 15.8 dB, respectively). In addition, the lateral resolution and penetration depth were increased by 95.4% and 40.3%, respectively. Consistent with the phantom experiment, in the in vivo experiment with ten patients, the CNR value for the SA method was 3.3 ± 0.5 compared to 2.8 ± 0.8 for the conventional method. Similarly, the SNR values with the SA-BiPBF and conventional methods were 34.0 ± 3.6 and 27.2 ± 3.4 dB, respectively. From the experiments, it was shown in side-by-side comparisons that the image quality of the SA-BiPBF method was considerably improved in both phantom and in vivo breast images. However, the SA-BiPBF image showed different features compared to the conventional one in the in vivo experiments. These features are resulting from the increased image quality of the SA-BiPBF method but are not always perceived as improvements by the radiologists.

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