International Psoriasis Council releases consensus statement on biosimilars

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

International Psoriasis Council releases consensus statement on biosimilars

Biosimilares/General | Posted 30/10/2020 0 Post your comment

The International Psoriasis Council (IPC) Biosimilar Working Group (BSWG) published their consensus statements for the use of biosimilars in the treatment of patients with psoriasis [1].

The IPC is a network of more than 100 psoriasis experts. With biosimilars becoming increasingly available worldwide, the IPC formed the BSWG to discuss the use of biosimilars in patients with psoriasis. The group aims to provide clear guidance on biosimilar use for clinicians, healthcare organizations, the pharmaceutical industry, regulators and patients.

Following their biannual meetings, the IPC BSWG created a series of 38 consensus statements related to aspects of biosimilars. These were reached through the nominal group technique (NGT), which had four stages: 1) Identification of essential issues on the use of biosimilars; 2) Discussion and collapsing of statements; and 3) Prioritizing and ranking statements through voting.

Overall, consensus was reached in 36 out of the 38 statements. These relate to the use of biosimilars for the management of psoriasis across 10 categories – biosimilar policy, cost of biosimilars, education, extrapolation of indication, interchangeability, naming, pharmacovigilance, regulatory considerations, substitution at the pharmacy level and traceability. Examples statements include: ‘Switching a stable patient from a reference product to a biosimilar product is appropriate if the patient and physician agree to do so’ and ‘Patients and patients’ organisations should be involved in all decision making and policy development about the use of biosimilars’.

The two statements over which consensus was not reached were: ‘Multiple switches between various biosimilars and reference biologics is not the preferred option but is acceptable’ and ‘Switching between different biosimilars should be performed with caution, until more evidence is generated supporting this practice’, which received only 65.7% and 73.9% positive opinions, respectively. These results indicate that switching between biosimilars in psoriasis treatment is still open to debate by members of the IPC.

In conclusion, the IPC members are positive about the evidence from clinical trials and increasing experience from clinical practice that show biosimilars to be equivalent to reference products in terms of their quality, efficacy, and safety. The IPC members have expressed reservations about switching and multiple switches between biological products. As such, they endorse continued patient monitoring in registry and long-term observational studies to give more information on the safety of multiple switches.

Conflict of interest
The authors of the research paper [1] declared that there was no funding to prepare the manuscript. However, several authors of the research paper [1] reported conflict of interest including having received financial support from pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [1].

Swiss position statement on the use of biosimilars in IBD

The ethics of generic immunosuppressive drugs

Reference
1. Cohen AD, Vender R, Naldi L, et al. Biosimilars for the treatment of patients with psoriasis: a Consensus Statement from the Biosimilar Working group of the International Psoriasis Council. JAAD International. 2020.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.