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 also with other biosimilars of the same reference medicine. As much as I would […]
Read MoreNon-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 with pharmaceuticals. However, they resemble biologics in terms of structural complexity, molecular weight range, physico-chemical stability, and […]
Read MoreDuis est enim, feugiat sit amet sollicitudin ut, mattis interdum quam. Ut euismod libero nec orci vulputate lobortis. Class aptent taciti sociosqu ad litora torquent per conubia nostra, per inceptos himenaeos. Phasellus sit amet nisi at tortor lacinia sodales. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; Aliquam fringilla eleifend […]
Read MoreDuis est enim, feugiat sit amet sollicitudin ut, mattis interdum quam. Ut euismod libero nec orci vulputate lobortis. Class aptent taciti sociosqu ad litora torquent per conubia nostra, per inceptos himenaeos. Phasellus sit amet nisi at tortor lacinia sodales. Vestibulum ante ipsum primis in faucibus orci luctus et ultrices posuere cubilia Curae; Aliquam fringilla eleifend […]
Read More