Infliximab-abda is the second infliximab biosimilar approved by the Food and Drug Administration, the agency announced April 21.
Infliximab-abda, to be marketed as Renflexis, is approved for all indications as the reference product, including Crohn’s diseases in adults and children, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis, according to the product label.
To gain FDA approval, infliximab-abda demonstrated that it has no clinically meaningful differences in terms of safety and effectiveness from the reference product (Remicade). Specifically, it meets the FDA regulations because it has only minor differences in clinically inactive components, has the same mechanism of action (to the extent that it is known) and route of administration, dosage form, and strength as the reference product.
Like Remicade, Renflexis will come with a boxed warning and a Medication Guide that describes important information about its uses and risks, which include serious infections, lymphoma and other malignancies, liver injury, blood problems, lupuslike syndrome, psoriasis, and in rare cases, nervous system disorders.
Renflexis will be marketed by Merck Sharp & Dohme and is manufactured by Samsung Bioepis.
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