FDA's Arthritis Advisory Committee overwhelmingly endorsed approval of Celltrion Inc.'s Inflectra (CT-P13) as a biosimilar to Janssen Biotech Inc.'s Remicade (infliximab) despite panelists' discomfort with some aspects of the 351(k) approval pathway and the lack of clinical efficacy data in all indications.
The committee voted 21-3 that based on the totality of evidence, CT-P13 should be licensed as a biosimilar to Remicade for each of the reference
Inflectra's Recommended Indications
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Adult and pediatric
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