Objective: The aim was to critically evaluate well-established regulatory agencies mAb\nbiosimilar guidelines for development and marketing authorization about quality, efficacy\nand safety and compare to BRICS-TM regulations to identify challenges.\nMaterials and Methods: The current valid guidelines of EMA, WHO, USFDA,\nBGTD/HC, ICH, and BRICS-TM were obtained from official websites and comparative\nqualitative review was performed.\nResults: The review revealed that Health Canada uses mAb specific guidelines\nfrom EMA or USFDA when necessary. The BRICS agencies (except Russia) have\nincorporated some or most of the WHO SBP TRS and related annexes in similar\nnational biotechnological/biological guidelines; however, gaps or insufficient information\nhave been identified. The Russian Federation has issued general product registration\nguideline/s with very brief information about mAbs. The TMMDA (Turkey) has published\nan updated biosimilar guideline which parallels those of the EMA and the ones from WHO;\nhowever, no mAb specific guidelines are published. COFEPRIS (Mexico) has published a\nbiotechnological/biological product registration guideline with no information about mAb.\nThe SAHPRA biosimilar guideline has an annex on mAbs which focuses on non-clinical\nand clinical aspects.\nThe comparative evaluation of BRICS-TM agencies indicates a gap pertaining to\nclarification for physico-chemical characterization, manufacturing process, overages and\ncompatibility requirements between biological substances and excipients specifically on\nmAbs. In vitro assay requirements seem quite aligned with those of WHO, whereas in vivo\nstudies mostly have disparity in terms of necessity, type of studies as well as design and\ncriteria. Clinical safety and efficacy studies are indicated in emerging regulatory agencies,\nhowever detailed information pertaining to design, size of populations, requirements for\nprimary and secondary endpoints, clarity and evaluation criteria differ. In general, BRICSTM\nagencies allow extrapolation of indications provided that pre-defined conditions are\nmet. Interchangeability, switching and substitution of biosimilars are not defined in most of BRIC-TM guidelines whereas South Africa, by law, allows neither interchangeability\nnor substitution. Pediatric research remains questionable across BRICS-TM.\nConclusions: EMA, USFDA guidelines are broadly aligned with WHO and in addition,\nthey also contain specific requirements pertaining to their own region. BRICS-TM\nhas considerably less defined mAb specific biosimilar development and comparability\nparameters in their published guidelines.
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