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SP0004 The Therapeutic Landscape in RA – Bdmards, Biosimilars and Beyond
  1. J.E. Fonseca
  1. Lisbon Academic Medical Centre, Lisboa, Portugal

Abstract

The use of biologic disease modifying anti rheumatic drugs (bDMARDs) has revolutionized the treatment of rheumatoid arthritis (RA). Innovation in this filed is continuous and several innovative bDMARDs that are currently on clinical trials will be reviewed. In addition, data coming from national registries has helped to fine tune the use of bDMARDs and this information will be also updated.

Biological therapies are large, highly complex molecules derived from living cells or organisms. Biological therapies have intrinsic variability, creating differences even between subsequent batches of the same product. In contrast to the traditional chemical medicines, which are simple molecules of low molecular weight, synthesized by chemical means that can be precisely reproduced after the expiring of the patent, biologics cannot. In addition, after expiring the patent access to the manufacturing conditions used in producing the originator therapy, including, for example, the relevant cell line clone and growth medium, is not granted. Therefore it cannot be guaranteed that biosimilar products are identical to their reference product on a molecular level. Thus, while conventional generic drugs require only a limited comparison and demonstration of identity to the reference product, biosimilars require a thorough comparison of structural and functional characteristics and a detailed preclinical testing, preceding phase I and phase III trials. Biosimilars offer a highly attractive strategy for reducing medical costs and increase accessibility to targeted biologic therapies. A landmark event for the future widespread use of biosimilars was the European Medicines Agency (EMA) approval of infliximab biosimilars. The post marketing surveillance, with special emphasis for the role of national registries, will be crucial for the confidence on the use of these biosimilars and will pave the way for the approval in the near future of other biosimilar candidates of biologics, such as rituximab, adalimumab and etanercept.

Another field of future opportunities for RA treatment are the inhibitors of intracellular signalling pathways, allowing oral administration, potentially less expensive and exploring new mechanisms of action that offer the promise of controlling an additional fraction of patients who still have persistent disease. Issues related to toxicity have limited its widespread use and this will be also detailed in this session.

Disclosure of Interest J. Fonseca Grant/research support from: Abbvie, Amgen, Celtrion, Celgene, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Abbvie, Amgen, Celtrion, Celgene, Janssen, MSD, Novartis, Pfizer, Roche, UCB

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