EADV News 52

News A u t umn 2 01 4 – N ° 5 2

Biosimilars in Dermatology

In this issue Editorial......................................................................... 3 President's Perspective.............................................. 4 Welcome to Amsterdam........................................... 5 Fostering Course: Chronic Wound Management and Telemedicine............................. 6 Update from the Fostering Trainee Education Committee.................................................................... 7 Dermatology in the Netherlands............................ 8 Notice of Annual General Meeting........................ 9 Trainee Course: Psyche and the Skin...................10 Update from the Scientific Programming Committee................................................................... 11 12 th EADV Spring Symposium in Valencia.........12 Trainee Course: Skin in Organ Transplant Recipients...............................................14 Call for Scholarship Applications: Valencia.......15 Website Committee Update...................................16 6 th EADV Dermatological Meeting in Ticino......17 Sister Societies' Update...........................................18 Interview with a Dermatology Resident ...........19 EADV Master Class, Belgrade.................................20 In Memoriam..............................................................21 Upcoming Fostering Courses.................................22 Calendar of Events....................................................23 … but more work needed The biosimilar must be identical or within the reference product range. Indeed, originators are also not identical to themselves as they may change over time, although companies are not showing data in support of the similarity between the initial and later originators. Similarity to the reference product must be demonstrated before starting continued on page 3 ss

require comparative pharmacokinetic clinical studies (commonly referred to as bioequivalence studies), whereas biosimilars must undergo rigorous head- to-head Phase I pharmacokinetic and pharmacodynamic and Phase III clinical testing (which can include multiple studies depending upon the mechanism of action for the various indications) to obtain regulatory approval. Biosimilars have an identical aminoacid (AA) sequence of the originator but may differ in the glycolisalation pattern and thus secondary and tertiary structures. Therefore, analytics is a very large component of the biosimilar development, whereas for originator the clinical development programme (phase III) is the most extensive part (Figure 1). The cost of phase III clinical studies may be too high to develop a commercially interestingbiosimilar. Analytics investigates AA sequence, molecular weight, protein concentrations and aggregation, and binding to the target cytokine, as well as the functional activity in in vitro assays (apoptosis induction, C1q assay, ADCC).

Prof Giampiero Girolomoni

B iological agents are widely used in dermatology particularly for the treatment of psoriasis and psoriatic arthritis. They include anti-TNF-x agents and ustekinumab, but in the very near future secukinumab, other anti-IL17 as well as anti-IL-23 drugs will be licensed. On the other hand, the patent of TNF- x agents is expiring. Infliximab EU patents expired in August 2014 and the etanercept EU patent will expire in February 2015. Therefore there is much interest in developing generics of biologics, which are called “biosimilars”.

More similarities than differences …

Biosimilars should be cheaper with a cost reduction of 20-30% compared to originators. Generic drugs generally only

New development

Biosimilar development

clinical studies biological PK/PD

clinical studies PK/PD

Figure 1: Differences in cost allowance between a new biological development and a biosimilar development

biological

analytical

analytical

Dermatology in Europe Focus on the Netherlands

12 th EADV Spring Symposium 5-8 March 2015 Valencia, Spain

EADV Master Class Non-Melanoma Skin Cancers

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See pages 12-13 ss

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EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

ACADEMIE EUROPÉENNE DE DERMATOLOGIE ET VÉNÉRÉOLOGIE

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