This symposium took place on 29th September 2016 as a part of the European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria
Chairperson: Matthias Augustin1
Speakers: Martin Schiestl,2 Sascha Gerdes3
1. University Medical Center Hamburg-Eppendorf, Hamburg, Germany
2. Chief Scientific Officer, Sandoz Biopharmaceuticals, Kundl, Austria
3. Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany
Disclosure: Prof Matthias Augustin has received grants and/or honoraria as a consultant, speaker, and/or advisory board member from AbbVie, Almirall-Hermal, Amgen, Biogen, Celgene, Centocor, Eli Lilly, GSK, Hexal AG, Janssen-Clag, Johnson & Johnson, Leo, Lilly, Medac, Merck-Serono, MSD, Novartis, Pfizer, Sandoz, UCB, and Xenoport. Dr Schiestl is an employee of Sandoz GmbH, Austria. Dr Gerdes has received consulting fees and/or received speakers’ honoraria and/or received grants and/or participated in clinical trials of the following companies: Abbott/AbbVie, Almirall-Hermal, Amgen, Bayer HealthCare, Biogen Idec, Bioskin, Boehringer Ingelheim, Celgene, Centocor, Dermira, Eli Lilly, Foamix, Forward Pharma, Galderma, Hexal AG, Isotechnika, Janssen-Cilag, Leo Pharma, Medac, Merck Serono, Mitsubishi Tanabe, MSD, Novartis, Pfizer, Sandoz Biopharmaceuticals, Schering-Plough, Takeda, Teva, UCB Pharma, VBL therapeutics, and Wyeth Pharma.
Acknowledgements: Medical writing assistance was provided by Dr Lucy Smithers of ApotheCom.
Support: The publication of this article was funded by Sandoz Hexal. The views and opinions expressed are those of the authors and not necessarily Sandoz Hexal.
Citation: EMJ Dermatol. 2016;4:39-46.
Prof Augustin opened the meeting and reviewed the use of systemic treatments recommended for moderate-to-severe psoriasis. Data indicating a lack of access to biologic treatments were presented, and barriers to the use of biologics, including both patient and physician-related cost, were discussed. The opportunity for improved access to biologic treatment options, portrayed by the availability of biosimilars, and the potential to improve healthcare for patients with psoriasis was presented.
Dr Schiestl explained that the demonstration of biosimilarity for regulatory requirements is based on the totality of evidence generated from analytical, non-clinical, and clinical data. The physicochemical and biological assessments performed for comparison of the proposed biosimilar and the originator molecule, using state-of-the-art technology, are most sensitive. Comparative, analytical, and functional testing therefore represent the major part of the comparability exercise, proving that the biosimilar and originator product contain essentially the same active substance. After demonstration of similarity at an analytical and functional level, suitable comparative pharmacodynamics (PDs) and/or pharmacokinetics (PKs) and/or safety studies in animal models are performed. Comparative clinical PKs/PDs and safety is
assessed in healthy volunteers as an essential part of the clinical development programme. A final confirmatory Phase III clinical study is conducted in a sensitive patient population to confirm similar safety and efficacy of the biosimilar compared to the originator molecule.
Dr Gerdes explained why psoriasis is a sensitive and robust indication for confirming clinical efficacy of a biosimilar. He presented data from the EGALITY confirmatory study of the etanercept biosimilar (GP2015) in patients with moderate-to-severe psoriasis to compare safety and efficacy, and provided data on multiple switches between the originator etanercept (ETN) and the biosimilar. The trial confirmed the clinical equivalence of the efficacy and safety of GP2015 with ETN; no new safety signals were observed. Switching between the originator and biosimilar had no effect on safety or efficacy over the 52-week study.
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