The number of biosimilars approved by the Food and Drug Administration (FDA) continues to grow in the United States, and they are slowly becoming available to consumers.
In late August, the FDA approved Cyltezo (adalimumab-adbm), a second biosimilar to Humira (adalimumab). But like the first biosimilar, Amjevita (adalimumab-atto), which was approved in September 2016, it is not yet available to U.S. consumers because of pending patent litigation with AbbVie, the manufacturer of Humira.
Continue reading FDA Approves A Fifth Biosimilar for Arthritis, But Three Are Still Not Available
The Food and Drug Administration (FDA) recently approved the biologic drug sarilumab (Kevzara) for the treatment of rheumatoid arthritis (RA). Sarilumab blocks a protein called interleukin-6 (IL-6), which plays a key role in many inflammatory diseases, including RA. It’s the second IL-6 inhibitor to receive FDA approval for RA; the other, tocilizumab (Actemra), got the nod in 2010.
Continue reading FDA OKs a New Biologic for RA
The U.S. Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a biosimilar to Remicade (infliximab), making it the fourth biosimilar approved to treat inflammatory types of arthritis.
Renflexis is the second approved biosimilar to Remicade. The first one, Inflectra (infliximab-dyyb), was approved in April 2016. This is the first time the FDA has approved two biosimilars for one original, “reference” medication.
Continue reading FDA Approves Second Remicade biosimilar
The U.S. Food and Drug Administration (FDA) on Friday approved the third biosimilar to treat inflammatory types of arthritis – but, like the two that were previously approved, this one will not be available to patients until patent disputes are resolved.
Continue reading FDA Approves Third Biosimilar for Arthritis – Amjevita, a Biosimilar to Humira