Rheumatology

Following close on the heels of its US approval for Ruxience (rituximab), Pfizer has gained the European Commission nod and aims to launch in coming months.
Self-insured companies could have saved $407 million to $1.4 billion in 2018 had they switched completely from reference biologics infliximab and filgrastim to biosimilars.
Mylan and Lupin have gained the necessary recommendation to begin marketing their etanercept biosimilar in Europe.
Alvotech Hf and DSH hope to get an adalimumab biosimilar approved in the United States, Europe, and selected Southeast Asia markets.
 
The American College of Rheumatology (ACR) has issued a list of recommendations for streamlining prior authorization to eliminate redundancy and improve access for patients.
 
In inflammatory rheumatic diseases, the nocebo effect may account for a portion of treatment failures among patients who were placed on biosimilars; however, discontinuations due to the nocebo effect can be difficult to diagnose due to the absence of diagnostic criteria, differences in pathologic backgrounds for each disorder, and the absence of specific neurochemical and neuroimaging studies, investigators found.
Stakeholder comments at a biosimilars forum staged by the FDA and Federal Trade Commission focused on improving the quality of information being disseminated about biosimilars and the need to make the approval process less burdensome for manufacturers.
 
Two regulatory experts said in an editorial that suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars.
 
The use of low-dose methotrexate in rheumatoid arthritis dates back more than 30 years, but despite these decades of clinical use, data on adverse effects have come mostly from observational studies rather than randomized controlled trials (RCTs), the authors say.
Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade. 

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