Biosimilar

Biotechnologically produced imitation products of biopharmaceuticals whose patent has expired. The active ingredient of biosimilars is comparable, but not identical, to the active ingredient of the already approved biotechnologically manufactured pharmaceutical ("reference product"). Hence the term "similarity" = similarity. Biosimilars are therefore not generics. Biosimilars represent a low-cost and equivalent alternative to initial supplier products.

Biosimilars and "generics" have nothing in common, apart from the fact that both are imitation products. This is already visible in the size of the molecule. Biosimilars are usually large, complex molecules. Generics, on the other hand, are rather small molecules. The production of biosimilars is complex. The products are subject to natural fluctuations so that the results of one production cycle (= batch) are not 100% identical to those of another. Deviations can also occur within a single batch. Biosimilars must always be approved at European level. For this purpose, the European Medicines Agency (EMA) has developed a special approval procedure via the CHMP (Committee for Human Medicinal Products).

The following dermatologically relevant biosimilars are available:

• Adalimumab: Amgevita®, Solymbic®
• Infliximab: Inflectra®, Remsima®, Flicabi
• Etanercept: Benepali®, Frelzi®
• Rituximab: Truxima®

The EMA requires a risk management programme for the marketing authorisation, which includes the safety specifications, a pharmacovigilance plan and a risk minimisation plan.

The first biosimilar for Infliximab will be available in 2015.

1. Radtke MA et al (2015) Biosimilars in the therapy of psoriasis - What do we expect as dermatologists. JDDG 13 (Suppl 1) 106-107