Anti-ABP34 monoclonal antibody

Introduction: Biosimilars, as defined by the European Medicines Agency, have been used in Europe since 2006. The landscape was considerably expanded when the first biosimilar of a monoclonal was approved and introduced in the European market. CT-P13 was developed by Celltrion as an infliximab biosimilar in 2013, not without controversy. As these complex molecules cannot be completely identical, some experts, clinicians, and even patients were skeptical regarding the real bioequivalence of the drugs. Currently, several new infliximab and adalimumab biosimilars are available or will reach the market in a few months. Areas covered: Our goal is to review, mainly from a clinical perspective, the available evidence for bioequivalence of anti-TNF biosimilars. We aim to take into account not only preclinical studies, mostly done for regulatory issues, but also data from clinical studies. Expert opinion: We can conclude that bioequivalence with originator is well demonstrated in those drugs which have followed European Medicines Agency regulatory pathways. Switching from originator to biosimilar appears safe for all indications. However, there are few data available for switching from one biosimilar to another, or for complete interchangeability. Prospective studies and strict pharmacovigilance are recommended.

Background: Intracranial pressure (ICP) normally ranges from 5 to 15 mmHg. Elevation in ICP is an important clinical indicator of neurological injury, and ICP is therefore monitored routinely in several neurological conditions to guide diagnosis and treatment decisions. Current measurement modalities for ICP monitoring are highly invasive, largely limiting the measurement to critically ill patients. An accurate noninvasive method to estimate ICP would dramatically expand the pool of patients that could benefit from this cranial vital sign. Methods: This article presents a spectral approach to model-based ICP estimation from arterial blood pressure (ABP) and cerebral blood flow velocity (CBFV) measurements. The model captures the relationship between the ABP, CBFV, and ICP wave-forms and utilizes a second-order model of the cerebral vasculature to estimate ICP. Results: The estimation approach was validated on two separate clinical datasets, one recorded from thirteen pediatric patients with a total duration of around seven hours, and the other recorded from five adult patients, one hour and 48 minutes in total duration. The algorithm was shown to have an accuracy (mean error) of 0.4 mmHg and -1.5 mmHg, and a precision (standard deviation of the error) of 5.1 mmHg and 4.3 mmHg, in estimating mean ICP (range of 1.3 mmHg to 24.8 mmHg) on the pediatric and adult data, respectively. These results are comparable to previous results and within the clinically relevant range. Additionally, the accuracy and precision in estimating the pulse pressure of ICP on a beat-by-beat basis were found to be 1.3 mmHg and 2.9 mmHg respectively. Conclusion: These contributions take a step towards realizing the goal of implementing a real-time noninvasive ICP estimation modality in a clinical setting, to enable accurate clinical-decision making while overcoming the drawbacks of the invasive ICP modalities.