Browsing by Subject "Biosimilar Pharmaceuticals"

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    Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021.
    (Nature reviews. Rheumatology, 2022-08) Coates, Laura C; Soriano, Enrique R; Corp, Nadia; Bertheussen, Heidi; Callis Duffin, Kristina; Campanholo, Cristiano B; Chau, Jeffrey; Eder, Lihi; Fernández-Ávila, Daniel G; FitzGerald, Oliver; Garg, Amit; Gladman, Dafna D; Goel, Niti; Helliwell, Philip S; Husni, M Elaine; Jadon, Deepak R; Katz, Arnon; Laheru, Dhruvkumar; Latella, John; Leung, Ying-Ying; Lindsay, Christine; Lubrano, Ennio; Mazzuoccolo, Luis Daniel; Mease, Philip J; O'Sullivan, Denis; Ogdie, Alexis; Olsder, Wendy; Palominos, Penelope Esther; Schick, Lori; Steinkoenig, Ingrid; de Wit, Maarten; van der Windt, DA; Kavanaugh, Arthur; GRAPPA Treatment Recommendations domain subcommittees
    Since the second version of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations were published in 2015, therapeutic options for psoriatic arthritis (PsA) have advanced considerably. This work reviews the literature since the previous recommendations (data published 2013-2020, including conference presentations between 2017 and 2020) and reports high-quality, evidence-based, domain-focused recommendations for medication selection in PsA developed by GRAPPA clinicians and patient research partners. The overarching principles for the management of adults with PsA were updated by consensus. Principles considering biosimilars and tapering of therapy were added, and the research agenda was revised. Literature searches covered treatments for the key domains of PsA: peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis; additional searches were performed for PsA-related conditions (uveitis and inflammatory bowel disease) and comorbidities. Individual subcommittees used a GRADE-informed approach, taking into account the quality of evidence for therapies, to generate recommendations for each of these domains, which were incorporated into an overall schema. Choice of therapy for an individual should ideally address all disease domains active in that patient, supporting shared decision-making. As safety issues often affect potential therapeutic choices, additional consideration was given to relevant comorbidities. These GRAPPA treatment recommendations provide up-to-date, evidence-based guidance on PsA management for clinicians and people with PsA.
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    Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.
    (Health Aff (Millwood), 2014-06) Grabowski, Henry G; Guha, Rahul; Salgado, Maria
    In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market currently requires large investments of money, fewer biosimilars are expected to enter the biologics market than has been the case with generic drugs entering the small-molecule drug market. Additionally, given the high regulatory hurdles to obtaining interchangeability-which would allow pharmacists to substitute a biosimilar for its reference product, subject to evolving state substitution laws-most biosimilars will likely compete as therapeutic alternatives instead of as therapeutic equivalents. In other words, biosimilars will need to compete with their reference product on the basis of quality; price; and manufacturer's reputation with physicians, insurers, and patient groups. Biosimilars also will face dynamic competition from new biologics in the same therapeutic class-including "biobetters," which offer incremental improvements on reference products, such as extended duration of action. The prospects for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should increase over time because of both demand- and supply-side factors.