One of the questions I am most often asked at workshops and by aspiring biosimilar developers is, which physicochemical and biological parameters should be included in a comparability study to demonstrate biosimilarity between a reference product and candidate biosimilar. The short an easy answer is to say that any attribute or characteristic that has an […]
Read MoreWe want to hear from you! This #GlobalBiosimilarsWeek, share your stories, information and educational resources, and initiatives so we can build a better world for biosimilars— together. Join the movement — be the voice of #biosimilars! https://bit.ly/GlobalBiosimilarsWeek #GlobalBiosimilarsWeek #GlobalBiosimilarsWeek is here, and education is a key step in understanding the importance of biosimilar adoption. This […]
Read MoreGreater access to #biosimilar = more care for more patients. https://bit.ly/GlobalBiosimilarsWeek #GlobalBiosimilarsWeek #Biosimilars are the key to building a better future for patients around the globe. In order to provide more patients with more care, we need policies that support greater access to biosimilar medicines. #GlobalBiosimilarsWeek Join us in celebrating #GlobalBiosimilarsWeek! https://bit.ly/GlobalBiosimilarsWeek
Read MoreWith the lower treatment costs achieved thanks to #biosimilars, we can re-invest in other health care services – like childcare, eldercare, mental health services, research and more. #GlobalBiosimilarsWeek Biosimilars treatment costs for patients, government health programs and other payers, budget resources can be devoted to other health care initiatives. https://bit.ly/GlobalBiosimilarsWeek #GlobalBiosimilarsWeek By lowering treatment costs, […]
Read MoreThe continued development of #biosimilars will promote health equity and access to care for millions of patients worldwide. Join the conversation with #GlobalBiosimilarsWeek. #Biosimilars: the future of sustainable healthcare. #GlobalBiosimilarsWeek This #GlobalBiosimilarsWeek, join us in looking at the road ahead for the #biosimilars industry. As more biosimilars are developed and approved, they will promote health […]
Read MoreQ: What are #biosimilars? A: Biosimilars are biologic medicines that are highly similar to a previously approved reference biologic. Biosimilars provide an opportunity to create competition in the market and expand patient access to critical medicines. #GlobalBiosimilarsWeek https://bit.ly/GlobalBiosimilarsWeek Safe and effective #biosimilars have been available for over 15 years. As more biosimilars come to market, […]
Read MoreFrom the desk of Henry Leng Extrapolation, when used in the context of biosimilars, means their registration for all the indications of the reference product without the need to conduct clinical trials to support each of those indications. The assumption that is made by most regulatory specialists, whether from industry or the regulatory authority, is […]
Read MoreFrom the Desk of Henry Leng The availability of biosimilars provides an affordable treatment option for many patients suffering from debilitating chronic diseases (rheumatoid arthritis, psoriasis, several cancers, etc.) who previously had no access to biologics because of the high cost of the patent-protected innovator medicines. However, the full potential of biosimilars in South Africa will […]
Read MoreFrom the desk of Henry Leng The guideline for the registration of biosimilars in South Africa, Biosimilar medicines: quality, non-clinical and clinical requirements, was first published in 2012; yet it took six years for the first biosimilar to be registered (Filgrastim Teva in 2018). Biosimilar registration applications were already received in since 2006 by the Medicines Control […]
Read MoreThe International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, welcomes the UK MHRA publication of its updated guidance on the licensing of biosimilar products (10 May 2021). This publication marks a positive milestone in the evolution of evidence requirements for biosimilar approval through the removal of the […]
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