Non-biological complex drugs (NBCDs) represent a class of diverse synthetic drugs midway between conventional low molecular weight chemical drugs and high molecular weight biologics in terms of complexity. Apart from their chemical origin, NBCDs have little in common...
From the desk of Henry Leng – In my post of three months ago (published May 21, 2022) I have argued that the time has come for SAHPRA to revise its guideline for the registration of biosimilars by, firstly, evaluating the need for in vivo pharmaco-toxicological...
From the desk of Henry Leng – One of the limitations in the development of biosimilars is the availability of reference products for use in comparability studies. Generally there are two options open to biosimilar manufacturers to obtain reference products –...
Just over ten years ago I was part of a collaborative research project that investigated how the complex interplay of patent regimes, pharmaceutical regulation, engagement by foreign donors and civil society, local production capacity, health systems and supply chain...
The South African Biosimilars guideline (1) was finalised for implementation in August 2014. In the almost eight years since its publication, a significant amount of progress has been made in the development of this type of biologic, its regulatory assessment and...
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