Automatic exchange of biopharmaceuticals – politicians must overturn the entire regulation
08.12.2022 17:27
The Federal Joint Committee (G-BA) has initiated the comment procedure for biotechnologically produced biological finished medicinal products by pharmacies for parenteral preparations for direct medical use. This means: From now on he is working on a regulation according to which pharmacies are obliged to exchange prescribed biotechnologically produced medicines if they are parenteral preparations from finished medicines for direct medical use on patients - just like with generics.
After the Federal Ministry of Health postponed the automatic substitution last summer due to massive concerns from doctors, patients and pharmacists as well as from industry, the G-BA is now resuming the process as announced. But this initiates a development whose consequences we can see very clearly, especially in these times. The current delivery bottlenecks for generics are the consequence of this very interchangeability, which has long been the case for generics - and which has fatal consequences for patient care. Because it increased the pressure on prices and production costs to such an extent that some breast cancer drugs were no longer available in Germany.
Walter Rohrer, Chairman of the AG Pro Biosimilars: “The G-BA has restarted the procedure because it has the legal mandate to do so. Nevertheless, automatic substitution in pharmacies is an aberration overall. Politicians must finally recognize this. We remain against it. And the unstable supply situation we are currently seeing for generics should be a warning sign to everyone. Because: Automatic substitution for biopharmaceuticals means making the generic mistake a second time.”
Especially since an automatic exchange is not necessary. Even without it, we see massive savings: in the area of parenterals manufactured in pharmacies, for example, a mandatory discount of 67.5 percent applies to biosimilars for medicines with the active ingredient trastuzumab.
In the months before the G-BA procedure was postponed by a year, representatives of doctors, patients and pharmacists had repeatedly spoken out against the equal treatment of biopharmaceuticals and generics. Rohrer said: “The controversy that we have had in recent years has not gone away. The regulation is still as controversial today as it was in the beginning. It’s not needed – and it’s extremely dangerous.”