by webmaster | Jun 24, 2023 | The Blog
Several attempts have been made in the past ten years or so to establish a local biosimilar manufacturing industry. A few start-up companies have been established and some even managed to obtain funding from the Technology Innovation Agency and other funding bodies,...
by webmaster | May 5, 2023 | The Blog
Nitrosoamine impurities have been a major concern to regulators and the pharmaceutical industry since 2018 when N-nitrosodimethylamine (NDMA) was discovered in the angiotensin-II receptor blocker (ARB), valsartan. Since then, nitrosamine impurities have been detected...
by webmaster | Mar 27, 2023 | The Blog
It is widely acknowledged that South Africa needs its own biosimilar manufacturing industry, and in my view, there is no better time than the present. The technology required for their production and control has become standardised and the risks associated with the...
by webmaster | Mar 1, 2023 | The Blog
The SAHPRA, like many other developing country regulatory authorities with capacity constraints, has implemented in 2019, a reliance approach for the registration of medicines, to reduce registration timelines and speed up access to new medicines, including...
by webmaster | Feb 17, 2023 | The Blog
After months of writing about it, and even raising the issue among regulatory stakeholders, SAHPRA has now finally agreed to amend the guideline and publish a statement to declare that biosimilars are interchangeable with their reference products (or vice versa) and...
by webmaster | Dec 8, 2022 | The Blog
I have written before about insulin – a simple biologic with arguably the least stringent regulatory requirements for registration as a biosimilar, yet with no or little interest by companies in the biosimilars space – both locally and in countries with...
