While the demonstration of bioequivalence is sufficient for generics of small synthetic drugs, this approach is not scientifically applicable to biosimilars.

Biologicals are usually large, complex molecular structures derived from or produced in living organisms, making them very difficult to replicate. Even for the originator biological, small changes in the manufacturing process can cause changes in the final product, making things even more complicated for potential biosimilars. Therefore, biosimilars of such molecules can only be similar, but not identical, to the originator and are also subject to different related post-translational processes. This is of concern for physicians, who worry that if a reference product and its biosimilar are not structurally identical they might not be therapeutically equivalent.

The development process for a biosimilar ensures a comparable risk-to-benefit balance compared with the originator biological, therefore, there are no grounds to believe that the use of a biosimilar carries more risks for the patient than the use of an originator biological. Internists should be also reassured with regard to immunogenicity and safety issues. It is well known that the problem of epoetin antibody-induced pure red cell aplasia (PRCA) was first recognized after the formulation of the originator epoetin Eprex (epoetin alfa) was changed [2].

Furthermore, there is a need for the dissemination of clear information about existing guidelines, access to unbiased information and educational interventions regarding the clinical utility of biosimilars. The aim of this should be to help internists to improve their knowledge and to implement the use of these medications in clinical practice. In Europe, there is a clear gap between the regulatory decisions that govern biosimilar approval and the recommendations of medical societies. The fact that the views of medical societies, whose members are the physicians that will prescribe biosimilars, disagree with those of regulators, threatens to hold back biosimilar uptake [3]. The need for the benefits of biosimilars to be communicated has also been highlighted at a biosimilars roundtable organized by GaBI in Brussels, Belgium on 12 January 2016 [4].

The scientific principles used for defining comparability are the same as those applied to an already approved originator biological after a significant change in its manufacturing process. Starting from this evidence, internists should only prescribe medicines for which the quality, safety and efficacy have been demonstrated according to state-of-the-art science and technology, irrespective of whether they are originator biologicals or biosimilars.

The authors conclude that the future development of biosimilars will depend on the definition of reliable parameters of interchangeability and will require further advances in knowledge on the characterization of the molecules. Internists, as well as other clinicians, along with healthcare providers and patients will play a key role in determining how biosimilars are integrated into clinical practice.

In order to facilitate understanding, the authors also list a number of ‘essential references’ for internists concerned about biosimilars.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Editor’s comment
Readers interested to learn more about biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Roundtable on biosimilars with European regulators and medical societies 

If you are interested in contributing a research article in a similar area to the GaBI Journal, please send us your submission here.

Related articles
Doctors’ survey reveals lack of confidence in biosimilars

Factors supporting a sustainable European biosimilars market

References
1.  Pasina L, Casadei G, Nobili A. Biological agents and biosimilars: essential information for the internist. Eur J Intern Med. 2016;33:28-35.
2.  GaBI Online - Generics and Biosimilars Initiative. Epoetin alfa and pure red cell aplasia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 25]. Available from: www.gabionline.net/Biosimilars/Research/Epoetin-alfa-and-pure-red-cell-aplasia
3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars: clinicians and regulators need to talk [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 25]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-clinicians-and-regulators-need-to-talk
4.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars: the benefits need to be communicated [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 25]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilars-the-benefits-need-to-be-communicated

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