The German Biosimilars Breakthrough That Never Was

It looked as if Germany had, via a new law in place since Oct. 1, allowed automatic substitution of biologicals with biosimilars. Such a move would have shaved 25% off the country's pharmaceuticals budget and set an important precedent in this nascent field, whose commercial success has so far been severely dampened by the restrictions on such substitution. There was plenty of excitement over the summer.

But it was misplaced. The legislation is in fact far more restrictive. The law permits a pharmacist to substitute a product for “an identical product”, even if the brand name is different. This could happen if a doctor prescribes only by active ingredient or does not rule out the substitution of a branded product for a product that contains the same active ingredient.

It sounds rather like generic substitution, but of course this cannot be the case, because biosimilars are not copies of the originator, they are simply “similar” – and this is the crux of the issue. The leading group of health insurers and the German pharmacists association have therefore agreed that in the case of biological products only those biologics that contain the same raw material and undergo the same manufacturing process are “bio-identical” and qualify for substitution.

This basically means that pharmacists may substitute biosimilars for biosimilars – and not for originators. Just to make sure that no-one confuses the issue any further, the agreement lays down specific substitution groups. For example, the first group consists of Medice’s Abseamed, Sandoz’s Binocrit, Hexal's Epoetin Alfa, because the epoetin alfa active ingredient in all of them is supplied by the same production firm.

So original biotech products remain a protected species for now, much to the frustration of the generics industry association, ProGenerika, which points out that substituting biosimilars for one another does not save any money. Instead, it discourages companies from manufacturing these expensive products because they face immediate competition.

But, leaving the summer madness behind us, there may yet be some hope on the horizon for a quiet revolution for biosimilars in Germany. A guideline on the administration of erythropoietin stimulating agents for the treatment of symptomatic renal anemia came into force at the end of September. It endorses the findings of the European Medicines Agency and states that ‘all available ESAs should be considered comparable in terms of therapeutic application’. The quality, safety and efficacy of approved biosimilars has been ‘adequately proven in the approved indications’, it adds. The first shot has been fired.

-- Faraz Kermani

image by flickrer caribb used under creative commons