In rheumatology, there are lots of new
concepts to learn nowadays.
Most people already know, what biologics
are. Biologics
are biopharmaceutical products that have been in use for about two decades in
rheumatology. These are for instance Remicade (infliximab), Enbrel
(etanercept), Humira® (adalimumab), Kineret® (anakinra), Orencia® (abatacept),
Mabthera® (rituximab), Actemra® (tocilizumab), Simponi® (golimumab), Cimzia®
(certolizumab) Benlysta® (belimumab), Prolia® (Denusomab) Ilaris®
(canakinumab), Stelara® (ustekinumab), Cosentyx® (Secukinumab).
Biosimilars are generic biologics that may be
approved after patent expiry of the original drug. Biosimilars are not
completely identical to the original products. Biosimilars must demonstrate
bioequivalence in studies. In Germany currently we have infliximab biosimilars
and a etanercept biosimilar.
Infliximab Biosimilars: Remsima®, Inflectra®,
Flixabi®.
Etanercept biosimilar: Benepali®.
Biomimics are generic biologics like biosimilars, but they do not
meet the requirements for bisosimilars. Another term for these biomimics is
"intended copies". More here:
http://rheumatologe.blogspot.de/2016/01/biomimics.html (English text). At the
recent European rheumatology annual meeting (EULAR 2016 in London), I saw a
poster by M. Scheinberg and colleagues under the title: "Variability of
Intended Copies for etanercept in 5 Countries". They showed significant
differences. These Biomimics do not have approval in Germany.
What are bioidenticals?
Bioidenticals are generic biologics of the same production. So these are
identical to each other. One can imagine this: a production is bottled in
vials, but have different labels. Currently this applies only to infliximab in
Germany. Remsima® and Inflectra® come from one production (Celltrion in South
Korea).
If a biologic (in this example: Remsima®,
Inflectra®, Flixabi®) is prescribed by trade name (for example Remicade), an
exchange by a biosimilar (Remsima®, Inflectra®, Flixabi®) is not possible. A prescription
under the generic name (in this example: infliximab) is rated as "unclear prescription",
so that the pharmacist is not allowed to give out any drug. Bioidenticals are
an exception; these can be exchanged according to discount agreements. Remsima®
and Inflectra® could therefore be used interchangeably.
In summary, it looks more complicated
than it is.
(Translation of a German text on this blog)
