FDA Panel Backs Pfizer and Celltrion's Remicade Biosimilar Over J&J's Objections

Tuesday, February 9, 2016

Source: FierceBiotech

A group of independent FDA advisers voted in favor of OK'ing Pfizer ($PFE) andCelltrion's take on the blockbuster inflammation treatment Remicade for all of the reference drug's approved indications, unswayed by protests from Johnson & Johnson ($JNJ).

The agency's arthritis panel voted 21-3 in support of approval for Inflectra, a biosimilar developed by South Korea's Celltrion and co-marketed with Pfizer. In clinical development, the treatment proved itself similar to J&J's Remicade in rheumatoid arthritis and ankylosing spondylitis, and the panel signed off on approving it for psoriatic arthritis, Crohn's disease, ulcerative colitis and psoriasis, as well.

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