Friday, August 12, 2016

Bioidenticals - Biosimilars - Biologics - Biomimics

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: (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)

No comments:

Post a Comment