The psoriasis treatment paradigm includes biosimilars into the biologics category of effective and safe systemic therapies. A biosimilar is highly similar to its reference biologic and has no clinically meaningful differences in efficacy, safety, or immunogenicity to the reference product. Approval of biosimilars must meet the rigorous standards of regulatory guidance. Biomimic products, however, are not included into the category of biosimilars since they have not demonstrated bioequivalence to their reference product through a stringent approval pathway.
IPC’s 2019 biosimilars initiative focuses on educating healthcare practitioners around the globe on the similarities and differences between reference biologics, biosimilars and biomimics. Dermatologists require the most current information in this rapidly evolving field in order to better understand the benefits and risks of biosimilar products and ultimately integrate their use into practice to improve patient outcomes.
The resources provided here offer background information on biosimilars, suggest practical guidance on communicating biosimilar benefits to patients, and present real-world clinical scenarios of psoriasis management with biosimilars.
Below are links to trusted resources on biosimilars. While not specific to dermatology, these resources can help increase your knowledge of how biosimilars are developed, approved, and used.
These programs are sponsored in part by Samsung Bioepis and Biogen.
Preparing for Biosimilars Lars Iversen, MD, DMSc., Aarhus University Hospital In his live remarks given at the 2019 World Congress of Dermatology, Prof. Iversen covers the basics of biosimilars including important terms and definitions, data on switching from a reference biologic to a biosimilar, and safety data. [19:58]
Biosimilars in clinical practice: Two real-world cases Lars Iversen, MD, DMSc., Aarhus University Hospital Through two challenging case presentations, Prof. Iversen highlights the use of biosimilars with a focus on switching, and the nocebo effect. [15:15]
IPC Biosimilars Working Group members have reviewed country-specific regulatory guidelines for approval of biosimilars. In addition, the group has examined biosimilar issues such as extrapolation, interchangeability, automatic substitution in the clinical setting, and pharmacovigilance. The following manuscripts are a product of this work. Learn more about the Biosimilars Working Group.
Cohen AD, Wu JJ, Puig L, Chimenti S, Vender R, Rajagopalan M, Romiti R, de la Cruz C, Skov L, Zachariae C, Young HS, Foley P, van der Walt JM, Naldi L, Prens EP, Blauvelt A. Br J Dermatol. 2017 Dec;177(6):1495-1502. doi: 10.1111/bjd.15756. 28646580, Epub 2017 Nov 27.
Abstract
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.
Link to PubMed
Blauvelt A, Puig L, Chimenti S, Vender R, Rajagopalan M, Romiti R, Skov L, Zachariae C, Young H, Prens E, Cohen A, van der Walt J, Wu JJ. Br J Dermatol. 2017 Jul;177(1):23-33. doi: 10.1111/bjd.15067. Epub 2017 May 28
Biosimilars are drugs that are similar, but not identical, to originator biologics. Pre-clinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to ultimately determine biosimilarity. In this review written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability, and optimal clinical trial design.
de la Cruz C, de Carvalho AV, Dorantes GL, Londoño Garcia AM, Gonzalez C, Maskin M, Podoswa N, Redfern JS, Valenzuela F, van der Walt J, Romiti R. J Dermatol. 2017 Jan;44(1):3-12. doi: 10.1111/1346-8138.13512. 27461455, Epub 2016 Jul 27.
Latin American countries view biosimilar agents as an effective approach to curtail health-care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country-specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health-care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes.
Link to full publication
Biosimilars, or sometimes called "generic biologics," are no longer a vision for the future, but a present-day reality. Drug manufacturers and regulatory authorities are charged with ensuring these products are safe and effective. Because biologically produced medications are large complex proteins, many factors affect the quality of the end-product, including glycosylation and presence of impurities, and thus many factors need to be compared between an emerging biosimilar and its originator partner biologic. Indeed, pre-clinical analytical assessments to determine similarity to an originator biologic are critical and are considered to be the foundation for regulatory approval of biosimilars. Here, the science behind the pre-clinical development of biosimilars is discussed by members of the International Psoriasis Council, and suggestions are put forth to try and ensure that future biosimilars are produced in a high quality and standardized manner.
The entry of biosimilar forms of biopharmaceutical therapies for the treatment of psoriasis and other immune-mediated disorders has provoked considerable interest. Although dermatologists are accustomed to the use of a wide range of generic topical agents, recognition of key differences between original agent (ie, the name brand) and the generic or biosimilar agent is necessary to support optimal therapy management and patient care. In this review we have summarized the current state of the art related to the impending introduction of biosimilars into dermatology. Biosimilars represent important interventions that are less expensive and hence offer the potential to deliver benefit to large numbers of patients who may not currently be able to access these therapies. But the development of biosimilars is not quivalent to that of small molecule generic therapies because of differences in molecular structure and processes of manufacture. The planned regulatory guidelines and path to approval may not encompass all of these potentially important differences and this may have clinical relevance to the prescriber and patient. Consequently, we have identified a series of key issues that should be considered to support the full potential of biosimilars for the treatment of psoriasis; ie, that of increased access to appropriate therapy for the psoriasis population worldwide.
Crossfire Symposium: The Advent of Biosimilars | Degree of Similarity
On-Demand Webcast
Crossfire Symposium: The Advent of Biosimilars | Pharmacovigilance
Crossfire Symposium: The Advent of Biosimilars | Clinical Practice