What are biosimilars? Biosimilars are similar, but not
identical, versions of approved biological medicines no longer
protected by patents. How do biosimilars differ from “generic”
pharmaceuticals? Generic pharmaceuticals are usually relatively
simple, small-molecule drug products that can be manufactured
via chemical synthesis to create an exact replica of the
original product. By comparison, biosimilars are not required to
be identical copies of the original products because most
biological medicines are far more complex and it is therefore
virtually impossible to create exact replicas. Although an exact
copy of the original product is not required, it is essential to
create a biosimilar that has no significant differences to the
original product and is highly similar in terms of safety,
purity and efficacy. How are biosimilars regulated? Many
countries have established a legal framework to allow approval
of biosimilars via an abbreviated registration process. As with
all biological medicines, biosimilars a