The European Union’s regulatory agency, the EMA, has approved over 20 biosimilars, 4 of which are indicated for psoriasis and psoriatic arthritis. Each EU member country has its own approach to how biosimilars are prescribed and perceived once approved.
In Spain, physicians affiliated with the Psoriasis Group of the Academia Española de Dermatología y Venereología (AEDV) published an opinion article stating that the organization celebrates the incorporation of biosimilars into the treatment regimens for psoriasis and psoriatic arthritis because the new drugs are likely to decrease the high cost of biologic therapies, which have substantially improved the treatment of these conditions.1 In Spain, the high cost of biologics has prompted debate on the economic sustainability of the country’s public health system, so the combination of effectiveness and lower prices presented by biosimilar drugs has created great interest. Physicians, patients, and the pharmaceutical industry have all taken part in the Spanish national debate, much as they did years ago when generic drugs were introduced.
The AEDV states that the use of biosimilars should not imply a reduction in therapeutic efficacy, patient safety, or the prescriber’s freedom of choice. But they note that biosimilars, while representing savings, do not appear to offer advantages over reference biologics. Decisions about which drug to prescribe should not be based on economic considerations alone but rather scientific evidence, they say.
An important concern expressed by physicians prescribing a biologic or a biosimilar for psoriasis and psoriatic arthritis is that they find the right treatment for patients with moderate to severe chronic plaque psoriasis who have failed to respond to, are intolerant of, or have a contraindication for other systemic therapies, including cyclosporine, methotrexate, or psoralen plus UV-A therapy. Although this is the approved indication for both the reference infliximab biologic and the approved biosimilars, the AEDV is concerned that the approval of infliximab was supported by data from clinical trials in patients with rheumatoid arthritis (RA) and ankylosing spondylitis, and not specifically patients with psoriasis and psoriatic arthritis. This is referred to as “extrapolated indications,” and the AEDV calls for clinical trials involving psoriasis and psoriatic arthritis patients of the biosimilars to the degree possible in order to obtain direct information about efficacy and safety in these patients.
The decision to prescribe a biosimilar should be assessed on a case-by-case basis, the AEDV states, and patients must agree with the choice. In Spain, the decision about the interchangeability of biosimilars for the reference biologic is left to the physician. Biosimilars may not be automatically substituted for reference biologics.
The AEDV states that to best ensure patient safety, the biosimilar must submit to a pharmacovigilance program that is as vigorous as that applied to the reference biologic. Namely, each drug must be traceable and identifiable at all times to track possible adverse events.
Finally, the AEDV endorses clarity and precision in patient and prescriber information for biosimilars so that the prescriber and patient can make informed decisions about the acceptability of these medications. “We must take steps to inform and teach those concerned,” the AEDV states, and ideally, information should reflect consensus formed before the new drugs are used routinely.