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The European Medicines Agency approved the first biosimilar therapies for rheumatologic diseases in 2006, yet it took the passage of the Affordable Care Act in 2010 for the United States to begin playing catch-up. The FDA followed the pathway and framework the EMA set, culminating in the approval of biosimilar Zarxio (filgrastim-sndz, Sandoz) — an oncology drug — in 2015. Since this preliminary approval, there are now a handful of biosimilars approved in rheumatology with several more in the pipeline. However, as these drugs emerge, questions about pricing and what payers might be
Original Article: Biosimilars Set to Take a Big Market Share in the USNEXT ARTICLE
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...