Recommendatoins For The Use Of Biosimilars To Treat Rheumatological Diseases - Big Molecule Watch

The February edition of the Annals of the Rheumatic Diseases published a Recommendation titled, “Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.” A panel of rheumatologists, dermatologists, gastroenterologists, and pharmacologists, as well as patients and regulators, were assembled to conduct a study aimed at developing recommendations regarding the use and evaluation of biosimilars to treat rheumatological diseases.

According to the article, key topics and questions were developed amongst the group, and a systematic literature review of relevant publications and abstracts through 2016 was conducted. Principles and recommendations from 29 publications and 20 conference abstracts were then incorporated into the group’s findings. The authors generated five overarching principles and eight consensus recommendations encompassing clinical trials, immunogenicity, extrapolation of indications, switching between bio-originators and biosimilars, and cost.

Some of the findings include:

  • “Currently available evidence indicates that a single switch from a bio-originator to one of its biosimilars is safe and effective; there is no scientific rationale to expect that switching among biosimilars of the same bio-originator would result in a different clinical outcome but patient perspectives must be considered.”
  • “The contextual aspects of the healthcare system should be taken into consideration when treatment decisions are made.
  • “The availability of biosimilars must significantly lower the cost of treating an individual patient and increase access to optimal therapy for all patients with rheumatic diseases.”

The full article from the Annals of the Rheumatic Diseases is available for purchase here.

Download PDF