Category: The Blog

Interchangeability of Biosimilars

From 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 […]

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Evaluation & Registration Pathway for Biosimilars

From 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 […]

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