Deep Dive
Biosimilars: the hardest useful thing a manufacturer can do
A generic small-molecule medicine can be made chemically identical to the original. A biosimilar cannot.
Biological medicines are produced by living cell systems, and no two production systems yield molecules that
are structurally identical. A biosimilar must therefore be demonstrated to be highly similar, with
no clinically meaningful differences in safety, purity or potency — an evidentiary burden that is
orders of magnitude heavier than for a conventional generic.
That burden is why biosimilar manufacture is concentrated in a small number of countries, and why almost
none of it happens in Africa. It requires cell-line handling, upstream and downstream bioprocessing,
extensive analytical characterisation, comparative clinical work and an aseptic fill-finish operation
— each of which is a discipline in its own right.
Why the effort is worth it
Originator biologics are priced for the reimbursement systems of high-income countries. In oncology in
particular, that pricing places entire classes of treatment out of reach for public health systems
elsewhere — not partially, but absolutely.
Sothema launched its own range of locally manufactured oncology treatments. Lamia Tazi has stated publicly
that through these oncology biosimilars the company reaches six times more patients than the originator
products previously reached, delivering the same quality at a fraction of the cost.
A sixfold increase in reach, in oncology, is not a commercial metric. It is a description of who now
receives treatment.