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