Yet another biosimilar has been approved.
“Water, water, everywhere,
And all the boards did shrink;
Water, water, everywhere,
Nor any drop to drink.”
Coleridge – The Rime of the Ancient Mariner
On Sept. 23, the FDA approved Amjevita, Amgen’s biosimilar adalimumab to Humira, now making four approved agents in this space. The advisory boards have been overwhelmingly convinced with recent votes of 26 to 0. For rheumatologists and our patients, however, it is a case of “biosimilars everywhere and none of them to give” – that is if you live in the United States.
Currently rheumatologists and other practitioners are unable to prescribe these new agents which are in already in worldwide use. In Finland alone, they have saved their national health system more than 50% on their biologic therapeutic tab for tumor necrosis factor inhibitors. The only people making money in the United States now are lawyers litigating patent disputes.
If I sound angry that is because I am. Of course, there are some sticky issues left not least of which is interchangeability. On the other hand, if there was a biosimilar approved and it was of an agent I would consider first line for my patient, then I would use it to start unhesitatingly. Stay tuned.
Leonard H. Calabrese, DO
Chief Medical Editor, Healio Rheumatology
Professor of Medicine, Cleveland Clinic Lerner
College of Medicine of Case Western Reserve University
RJ Fasenmyer Chair of Clinical Immunology
Disclosures: Calabrese reports he is a consultant for Genentech, Pfizer, Bristol-Myers Squibb, GlaxoSmithKline, Sanofi, Jansen and AbbVie; and is on the speakers bureau for Genentech, AbbVie and Bristol-Myers Squibb and Crescendo Bioscience.