Biosimilars are increasingly available for the treatment of many serious disorders, however some concerns persist about switching a patient to a biosimilar whose condition is stable while on the reference biologic. Randomized controlled studies and extension studies with a switch treatment period (STP) to or from a biosimilar and its reference biologic were identified from publicly available information maintained by the U.S.
View Article and Find Full Text PDFDy -doped CaY Al SiO phosphors were prepared using the sol-gel method. X-ray diffraction (XRD), field emission scanning electron microscopy (FESEM), and energy dispersive spectroscopy analyses (EDS) were used to analyse the crystal structure, morphology, and elemental composition of the prepared samples. The luminescence behaviour of the sample was investigated using photoluminescence (PL) and thermoluminescence (TL) techniques.
View Article and Find Full Text PDFBiosimilar development has a well-documented foundation of product quality and extensive comparative analytics providing the bulk of the "totality of the evidence" that a proposed product is biosimilar to its reference product. This work provides a retrospective evaluation of a single critical quality attribute-high mannose glycans for monoclonal antibody biosimilars. Given the well-established conclusion that high mannose glycans can impact pharmacokinetic (PK) profile, we performed a retrospective evaluation of 21 monoclonal antibody biosimilar programs (those licensed before April 2022), their levels of glycans, and the methods used to study them.
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