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Portuguese dermatologists’ position on the use of biosimilars in psoriasis Posted 25/11/2016

Biologicals have revolutionized the treatment of psoriasis and psoriatic arthritis. However, they impose a heavy burden on the healthcare system due to their high costs. In 2013, 27% of pharmaceutical sales were for biologicals. In 2015, two of the top five best-selling therapies were tumour necrosis factor-alpha (TNF-α) inhibitors, adalimumab and etanercept. Biosimilars, which may cost 25−30% less than the originator biological, thus represent a significant opportunity for savings to be made by both patients and healthcare systems.

In February 2016 the Portuguese National Authority of Medicines and Health Products (INFARMED, IP) released a recommendation document about the use of biosimilars. Based on these recommendations, dermatologists from the Portuguese College of Dermatology and the Portuguese Society of Dermatology and Venereology have made their own recommendations to physicians. Tiago Torres and co-authors discuss these recommendations [1].

The Portuguese dermatologists’ position on the use of biosimilars in psoriasis is that:
• Biosimilars are welcomed in the treatment of psoriasis and psoriatic arthritis if they are able to reduce medical costs and increase access to biological therapy, improving patient’s care and providing saving and efficiency for healthcare systems, therefore, releasing resources for other important aspects of health care.
• In patients’ best interest, the development of biosimilars must be critically evaluated. Medical and immunological considerations, including high quality evidence of bioequivalence, quality, efficacy and safety of each developed biosimilar should always take priority over any economic or financial benefit.
• Many of the concerns raised regarding extrapolation may in the future prove to have no practical impact. However, since several biosimilars are being evaluated in psoriasis patients, these agents should be chosen to treat psoriasis patients instead of biosimilars studied in other conditions.
• There is no evidence to support switching between a reference biological and a biosimilar and vice versa, so this should not be recommended.
• Any decision to substitute a biosimilar product should only be made by the prescribing physician and automatic substitution is not recommended. Moreover, patients should be kept informed about their treatment agent, and should not be transitioned to other agents without their knowledge and informed consent.
• Biosimilars should be subjected to the same standards of pharmacovigilance as do the reference biological agents. Post-marketing surveillance, mainly through national registers, is crucial to permanently assess safety and increase confidence in the use of biosimilars.
• In the absence of an established international standardized system of nomenclature for biosimilars, careful biosimilar identification and recording (including the brand name and batch number) is of utmost importance for safety reasons and for securing traceability.
• Biosimilars should not prevent or delay access to therapeutic innovation, and physicians must retain full authority concerning the decision of which therapeutic agent is selected to treat their patients.
• These opinions may change with time. Daily clinical experience and new data will be of critical importance.

The authors note that the Portuguese INFARMED document clearly recommends ‘the use of biosimilars as it is associated with reduced therapy-related costs and increase patients’ access to biological therapies’. They also point out that ‘therapeutic agents with approved biosimilars’ are recommended as ‘the first choice of treatment’. For naïve patients, biosimilars are recommended as the first option where savings can be made and where the biosimilar is approved in the same clinical indications as the reference product, which the authors say removes the problem of extrapolation of indications.

The authors also point out that in the INFARMED document the ‘importance of pharmacovigilance and traceability is highlighted with recommendations regarding these aspects’. However, they also point to the fact that ‘no clear position is stated regarding switching between reference and biosimilars’. Finally, they note that ‘some concerns are expressed regarding safety issues, specifically immunogenicity’, adding that ‘it is recommended that any decision should be taken cautiously’ and should ‘always involve the clinicians that are responsible for patients’ care’.

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1. Torres T, et al. Portuguese Position Paper on the Use of Biosimilars in Psoriasis. Acta Med Port 2016 Sep;29(9):574-7.

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