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Equivalence is the key to biosimilars
Do biologic drugs remain the same over time?
Biologics are created in living organisms, such as bacterial, animal or human cell cultures, and have revolutionized the treatment of many disorders. Unlike chemically synthesized drugs, the complex nature of biologics and their manufacturing processes means that identical copies cannot be created. Consequently, batch-to-batch variability is inevitable for all biologic products. Here, Martin Dyer, DPhil, FRCP, FRCPath, discusses the inherent variability in the production of biologic drugs, referencing the biologic rituximab as an example. Rigorous screening and clinical evaluation ensure that we can have confidence in biologics.
What are biosimilars and how are they approved?
The European Medicines Agency regulation of biosimilar production is based on the procedures that are in place for assessing manufacturing changes of originator biologics. Central to this is demonstrating that there are no significant clinical differences between a biosimilar and its reference biologic. In this video, Martin Dyer, DPhil, FRCP, FRCPath, explains that the step-wise approach to the regulation of biosimilars is no less stringent to originator biologics, but that the balance of data required is different.
Biological variability is inherent. Mapping out the batch-to-batch variability of rituximab over time, it is clear that biologics do not stay the same. However, this is not a cause for concern, as regulatory authorities continue to monitor the quality and functionality of the drug.
Here you can find some of the evidence, recommendations and practical considerations for the adoption of biosimilar monoclonal antibodies.
Biosimilars are typically approved for all of the indications of the originator brand. Extrapolation of clinical efficacy and safety data to other indications of the reference biologic not specifically studied during the clinical development of the biosimilar, is possible based on the overall evidence of comparability provided from the comparability exercise and with adequate justification. Although clinical data are an important part of the regulatory review for a biosimilar, comparability with the reference drug based on non-clinical studies is an inherent part of the pathway.
Truxima®: clinical evidence and safety information
Truxima® in follicular lymphoma
The final stage of the biosimilar approval process is to determine whether any variability identified during the non-clinical testing has any effect on the performance of the drug compared to the reference product in patients. Here, Simon Cheesman, BPharm, MRPharmS, presents data comparing biosimilar intravenous (IV) rituximab, Truxima, to the originator IV rituximab, in patients with follicular lymphoma. It is important during such a study that a sensitive patient population is chosen and for relevant clinical endpoints to have been identified. In this example, Truxima was shown to be non-inferior to IV rituximab.
In addition to lymphoma, biosimilar rituximab has been indicated in the treatment of rheumatoid arthritis. Studies have found that biosimilar rituximab is equivalent to reference rituximab in terms of pharmacokinetics and efficacy, and highly similar in terms of efficacy and safety1–4.
Yoo DH, et al. Ann Rheum Dis 2017;76(3):566—570
Yoo DH, et al. BioDrugs 2017;31(4):357—367
Park W, et al. BioDrugs 2017;31(4):369—377
Park W, et al. mAbs 2018 Jul 16:1-10. [Epub ahead of print]
There are many decisions to be made when considering making the switch from an originator to a biosimilar. Here, Simon Cheesman, BPharm, MRPharmS, shares his experience of switching patients with advanced follicular lymphoma from originator IV rituximab to Truxima at University College Hospital, London, UK. As a pharmacist, Mr Cheesman realized that it was important for him to inform colleagues and patients about the use of biosimilar rituximab, and to assure them of its safety. He describes how the results from this switch were positive, with no significant differences in treatment outcomes or patient pathways.
Watch as Simon Cheesman, BPharm, MRPharmS, presents the real world experience of using biosimilar rituximab at University College Hospital, London, UK.
This presentation was recorded at the BOPA 20th Annual Symposium 2017, held in Glasgow, UK. Mr Cheesman discusses the practical implications of making the switch, as well as sharing data from the study.