HMR has been studying biologicals (‘large molecules’) for many years, in both healthy volunteers and patients. Our extensive clinical experience is matched by the HMR Pharmacy’s expertise in the manufacture of sterile products. We have 3 isolators, which ensure continuous availability of our aseptic service. When the need arises, we can use one of the isolators for sterile preparation of radiolabelled biologicals as well as ‘small molecules’.
Now that many biologicals are coming to the end of their period of patent protection, many manufacturers are researching and producing ‘biosimilars’ – generic equivalents of the proprietary products. Each new biosimilar requires a bioequivalence trial that includes comparison with the immunogenicity of the marketed product, and we’ve already acquired substantial experience of such trials.
We completed an adalimumab (‘Humira’) biosimilar trial in 180 subjects by ourselves (reference below). Recruitment took 4.5 months. The FDA inspected the trial, which was pivotal trial for the new drug application (NDA), and there were no findings.
Sample size for biologicals/biosimilars is often 160–180 subjects. We usually do the whole trial by ourselves, which we favour because it removes centre as a source of variability – particularly important in parallel-group trials.
Biological products that we’ve studied
- recombinant human proteins
- peptides
- vaccines – flu, hepatitis B, HIV, SARS-CoV-2 and Ebola viruses
- vaccines based on GMO (genetically modified micro-organisms – herpes, HPV)
- cytokines
- biosimilars
- ‘bio-betters’
- antisense
- small interfering RNAs
- monoclonal antibodies
- fusion proteins
Reference
Puri A, Niewiarowski A, Arai Y, Nomura H, Dalrymple I, Warrington S, Boyce M. Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy volunteers. Br J Clin Pharmacol 2017; 83:1405–1415