Browsing Research publications by Author "Rahalkar, Hasumati"
Now showing items 1-4 of 4
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Challenges Faced by the Biopharmaceutical Industry in the Development and Marketing Authorization of Biosimilar Medicines in BRICS-TM Countries: An Exploratory Study
Rahalkar, Hasumati; Sheppard, Alan; Lopez-Morales, Carlos Augusto; Lobo, Luciano; Salek, Sam (2021-07-22)Abstract: Background: Biosimilars are expected to emerge as a rapidly growing segment of the biopharmaceutical industry. However, the biosimilar industry faces multiple challenges and obstacles in developing and marketing ... -
Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices
Rahalkar, Hasumati; Sheppard, Alan; Salek, Sam (2021-08-09)Objectives: The aim of this study was to identify, compare and evaluate regulatory requirements for the biosimilar development and review processes in BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, Mexico) ... -
Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities
Rahalkar, Hasumati; Sheppard, Alan; Santos, Gustavo Mendes Lima; Dasgupta, Chitralekha; Perez-Tapia, Sonia Mayra; Lopez-Morales, Carlos A.; Salek, Sam (2021-09-09)Background: The aim of the study was to identify, interpret, and compare the current perspectives of regulatory agencies in six member countries of BRICS-TM (Brazil, Russia, India, China, South Africa, Turkey, and Mexico) ... -
Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines
Rahalkar, Hasumati; Cetintas, Hacer Coskun; Salek, Mir-Saeed Shayegan (2018-09-28)Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations ...