Clear conditions for biosimilars the best way to boost patient safety says Danish Pharmaceutical Association

When treating patients, patient safety is crucial. Regardless of whether this concerns biological, biosimilar or conventional/synthetic products and regardless of whether treatment is done in hospital or the primary sector, writes Mads Tang Dalsgaard, country director of Amgen in a blog for the  Danish Pharmaceutical Association (LIF).

And patient safety is best when everyone knows exactly the framework within which they are working. But this framework has not yet been clearly set. Because when it comes to biological or biosimilar treatment, what are the authorities' expectations, guidelines and requirements for the Regions, for attending physicians and for manufacturers of biological and biosimilar drugs? There are in fact no clear answers to that at present.

The EMA [European Medicines Agency] is responsible for approving new medicinal products. It issues clear guidelines for the indications for which biological or biosimilar drugs can be used. And that is fine. But what do the authorities in Denmark have to say subsequently about for example starting new treatments, extending treatments and possibly substituting or switching between biological and biosimilar medicines - which rules should the attending physician comply with?