Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice

TY - JOUR

T1 - Biosimilars for psoriasis

T2 - worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice

AU - Cohen, A. D.

AU - Wu, J. J.

AU - Puig, L.

AU - Chimenti, S.

AU - Vender, R.

AU - Rajagopalan, M.

AU - Romiti, R.

AU - de la Cruz, C.

AU - Skov, L.

AU - Zachariae, C.

AU - Young, H. S.

AU - Foley, P.

AU - van der Walt, J. M.

AU - Naldi, L.

AU - Prens, E. P.

AU - Blauvelt, A.

PY - 2017/12

Y1 - 2017/12

N2 - The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of ‘big data’ should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies.

AB - The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of ‘big data’ should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies.

U2 - 10.1111/bjd.15756

DO - 10.1111/bjd.15756

M3 - Review

C2 - 28646580

AN - SCOPUS:85031793743

SN - 0007-0963

VL - 177

SP - 1495

EP - 1502

JO - British Journal of Dermatology

JF - British Journal of Dermatology

IS - 6

ER -