The EU guideline, dated 10th November 2016, on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight-heparins states that “pivotal evidence for similar efficacy will be derived from the similarity demonstrated in physicochemical, functional and pharmacodynamic comparisons.” As such a comparative efficacy trial is not necessary.
This guideline describes the non-clinical and clinical requirements for low molecular weight heparins-containing medicinal products claimed to be biosimilar to another one already marketed. The guideline addressed quality, non-clinical (pharmaco-toxicological), pharmacokinetic, pharmacodynamic and, where needed, safety/immunogenicity requirements as well as pharmacovigilance aspects. In contrast to the parent guideline, which required a comparative clinical trial by default, the revised guideline does not. Instead it focuses on demonstration of biosimilarity based on robust and compelling physicochemical and functional data plus comparable pharmacodynamic profiles. Clinical immunogenicity data may not be necessary if the immunogenic potential can be adequately characterised in in vitro tests. In addition, the non-clinical section has been amended to follow a risk-based approach.
Click here to read the guideline.