Much has been made of the difficulty of producing biosimilar versions of biologic drugs that are particularly complex in structure and function: monoclonal antibodies and fusion proteins. The patent has expired for some of them, and will do so for many in the coming years. The debate arose a few years ago regarding monoclonal antibodies. Is it possible to generate a biosimilar from a monoclonal? The answer is yes. It has been given by the European Commission itself, authorizing the first biosimilar monoclonal (of infliximab) and more recently of the fusion protein, etanercept. Other monoclonals are currently under evaluation by the European Medicines Agency (EMA).
The current debate about the supposed risk of biosimilar versions of complex medicines such as monoclonal antibodies, of which we have already spoken in this blog, has made us return to the subject to clarify some more concepts about these second generation biosimilars.
Un monoclonal antibody (mAb) It is a biotechnological molecule that, in general, has a higher molecular mass, and greater structural and functional complexity, than that of other biotechnological active ingredients. These drugs work by highly selectively identifying a target, binding to it, and neutralizing or destroying it.
Given their complexity, a few years ago the debate began as to whether it would be possible to reproduce them in accordance with the comparability requirement established by the EMA biosimilarity condition.
From the approval of two second-generation medicines in the EU, it can be deduced that the development of the corresponding biosimilar versions of complex biotechnological medicines is possible, but that it requires adaptation in the number and nature of the comparison studies necessary to certify that comparability.
However, it cannot be anticipated whether or not it will be possible to create a biosimilar version of any of the original biotech drugs with monoclonal antibody as active ingredient, it will be the EMA who will evaluate case by case.
In any case, it should be noted that when the European Commission gives the 'green light' to a biosimilar, regardless of its complexity, it does so because, based on evidence, it understands that the guarantees of efficacy and safety offered by the biosimilar are equivalent to those of the original product and therefore that both drugs share the benefit/risk balance. It should not raise doubts.