Rheumatology

This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.
 
Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra).
This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.
Despite the extensive body of literature on rheumatoid arthritis (RA), the exact causes of the disease are not fully understood. Tumor necrosis factor alpha (TNF) is known to play a key role in the disease by stimulating catabolic processes and causing inflammation, and important elements of inflammation include changes in extracellular matrix compounds and their constituents, such as glycosaminoglycans.
As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders. 
AbbVie has struck agreements with multiple developers over biosimilar adalimumab, forestalling US market entry until 2023. Here's when each product could potentially reach US patients.
Samsung Bioepis, maker of Imraldi, has developed an autoinjector device that aims to address some of the mobility limitations that patients with rheumatoid arthritis may have in self-administering their adalimumab with a syringe.
Current treatment for cutaneous lupus erythematosus (CLE) commonly focuses on photoprotection, topical therapies, corticosteroids, antimalarial drugs, and immunosuppressive drugs. More recently, B-cell depleting therapies, such as rituximab, have shown promise in treating systemic lupus erythematosus, though the feasibility of treating CLE with rituximab has not been well described.
The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz). 
 
With the launch of some of the most highly anticipated products thus far in the biosimilar experience, and with the release of key new data on multiple biosimilar products, October 2018 was a memorable month for biosimilar stakeholders.

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