Biosimilars for the treatment of psoriasis

ABSTRACT

Introduction: Biosimilars are biological products that are very similar to their originators, with no meaningful differences in terms of efficacy, safety, and purity. Since the patents of some of the biologics used to treat patients with psoriasis have expired, uptake of biosimilars provides a good opportunity to reduce the cost of treatment.

Areas covered: In this review we summarize the stages in development of a biosimilar product, the main differences with the originator biologic, and their potential implications. We have also reviewed clinical trials of biosimilars approved for the treatment of psoriasis.

Expert opinion: Because of efficacy and convenience of administration, adalimumab biosimilars will be used to greater extent than etanercept or infliximab to treat patients with moderate-to-severe psoriasis. The pharmacokinetics, efficacy, safety and immunogenicity of approved biosimilars are equivalent to those of their reference products in clinical trials, and multiple-switch studies are intended to provide evidence in support of FDA-required interchangeability. Non-medical switching is expected to become frequent, and the nocebo effect will be relevant. Traceability of biologics is an essential requirement to gather relevant information on their long-term efficacy and safety, especially when multiple switches occur.

Trial registration: ClinicalTrials.gov identifier: NCT02850965.

Trial registration: ClinicalTrials.gov identifier: NCT03210259.

Trial registration: ClinicalTrials.gov identifier: NCT02660580.

Trial registration: ClinicalTrials.gov identifier: NCT01970488.

Trial registration: ClinicalTrials.gov identifier: NCT02016105.

Trial registration: ClinicalTrials.gov identifier: NCT01970475.

Trial registration: ClinicalTrials.gov identifier: NCT02744755.

KEYWORDS:

• Biosimilars
• biologics
• adalimumab
• etanercept
• infliximab
• interchangeability
• switching
• TNF inhibitors
• psoriasis
• hidradenitis suppurativa

Article highlights

• Biosimilars are biotherapeutic products that are highly similar in terms of quality, efficacy and safety to an already licensed reference biotherapeutic product.

• The process of manufacturing of a biosimilar product includes complex preclinical studies to confirm the purity of the protein to be injected in humans.

• Regulatory agencies require clinical equivalence studies to demonstrate similar pharmacokinetics, efficacy, safety and immunogenicity in at least one licensed indication of the originator or reference product.

• Adalimumab, for convenience and efficacy reasons, is the most suitable for the treatment of psoriasis of the anti-TNFα agents with available biosimilars.

• Since 2017, six biosimilars of adalimumab have been approved by the EMA, and four of them have performed clinical equivalence studies in patients with psoriasis.

• From 2019 on, following patent expiration of reference adalimumab in the EU, settling of legal and royalty agreements, and under the pressure of payers, widespread prescription of adalimumab biosimilars can be expected to take place by dermatologists caring for patients with psoriasis and hidradenitis suppurativa.

• This box summarizes key points contained in the article.

Declaration of interest

L. Puig has perceived consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by Abbvie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, Leo-Pharma, Lilly, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Regeneron, Roche, Sandoz, Samsung-Bioepis, Sanofi, and UCB. A. Lopez-Ferrer has received speaking fees and consultancies from Abbvie, Janssen, MSD, LeoPharma, UCB, Pfizer, Lilly and Novartis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

One of the peer reviewers on this manuscript declares to have received research, speaking and/or consulting support from a variety of companies including Galderma, GSK/Stiefel, Almirall, Alvotech, Leo Pharma, BMS, Boehringer Ingelheim, Mylan, Celgene, Pfizer, Ortho Dermatology, Abbvie, Samsung, Janssen, Lilly, Menlo, Merck, Novartis, Regeneron, Sanofi, Novan, Qurient, National Biological Corporation, Caremark, Advance Medical, Sun Pharma, Suncare Research, Informa, UpToDate and National Psoriasis Foundation. This reviewer also consultant for others through Guidepoint Global and Gerson Lehrman. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.