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 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 Arthritis Advisory Committee to the Food and Drug Administration (FDA) voted 21 to 3 on Tuesday (Feb. 9) to recommend approval of CT-P13, a biosimilar version of Remicade (infliximab), which is used to treat inflammatory types of arthritis, including rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosking spondylitis (AS). CT-P13 is the first biosimilar to treat arthritis to reach this milestone.
Similar but not identical
A biosimilar is highly similar to, but not exactly the same as the existing, FDA-approved biologic, called the “reference” drug (in this case Remicade). People are familiar with generic versions of brand-name drugs, but biosimilars are not generic drugs. Generic versions of brand-name drugs are exact copies of chemically synthesized medicines. Biosimilars are not-quite-perfect copies of biologics – drugs derived from living cells that are impossible to replicate exactly.
Continue reading FDA Panel Endorses Remicade Biosimilar, a First for Arthritis