“Why does the term ‘biosimilars’ suddenly arise now in association with ‘biotechnologicals’ – the genetically produced medicines to which we have just adjusted ourselves as a well-informed patient group?” he asked the audience. “Not very surprisingly, this has something to do with ‘money’,” he continued. “It’s because genetically produced medicines are expensive — in fact very expensive — and then one looks for alternatives. That’s alright, as long as one does not allow any compromises with regard to their efficacy and tolerance. And that’s actually indeed the case. However, one cannot force patients to substitute a familiar preparation by a new one because of cost reasons, also if it concerns a similar or supposedly identical one. That doesn’t seem to be guaranteed anymore in the future.”

Professor Dingermann explained that in a first-order approximation one may describe biosimilars as copies of biologicals – the genetically or via-recombinant-DNA-technology-produced agents. “However, this definition definitely falls short, because strictly one cannot copy genetically produced agents at all. That is connected with the fact that the manufacturing process of such a medicine plays an enormously important role. In fact, genetically produced medicines are eventually defined by the manufacturing process.”

“For medicines that you can take, e.g. as a tablet or drop, you say ‘The product is the molecule’. However, with genetically produced medicines – the so called ‘biologicals’ – that, as you know, all have to be injected, you say ‘The product is the process that produces this molecule’.”

According to Professor Dingermann, strictly that means that during the copying of a genetically produced molecule not ‘only’ the molecule has to be copied, but also the complete manufacturing process. “However, that’s absolutely impossible. In the first place because in such a process a multitude of firm secrets are concealed, which won’t appear in any publication or patent. In the second place, because naturally a change of manufacturing plant means already a process change. And of course no manufacturer of such a complex medicine would allow some other manufacturer wanting to produce a copy of that medicine to manufacture this copy in his plant.”

He concluded that biosimilars therefore need to be classified totally different than the classical agents that we call ‘generics’.

References:
Professor Theo Dingermann. Biosimilars – Business as usual oder eine neue pharmazeutische Herausforderung. ABDA Wochenendworkshop Patient und Pharmazeutische Betreuung;17–18 October 2009; Hannover, Germany.

Pharmazeutische Betreuung: Mut zur Kommunikation. Pharmazeutische Zeitung. 43/2009.