J&J, Schering biologic wins FDA approval

Johnson & Johnson and Schering-Plough have won FDA approval for Simponi (golimumab), an injectable biologic drug for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. These chronic inflammatory diseases, which plague roughly 3 million Americans, result in pain and inflammation--and in some cases, joint destruction and disability. The drug was also approved in Canada earlier this week.

Simponi is an update to the $5 billion-a-year blockbuster drug Remincade and will compete with Amgen;s Enbrel and Abbott Laboratories' Humira. Simponi's biggest advantage? It requires only injections rather than in-office infusions, and is the first monthly subcutaneous anti-TNF-alpha therapy. "It's a big drug," Gabelli & Co. analyst Jeff Jonas told Bloomberg. "It'll definitely be over $1 billion, which is blockbuster status, but it'll probably reach $2 billion or $3 billion over the next few years."

"With the approval of Simponi, we enhance our commitment to delivering effective and innovative treatments to the millions of patients living with chronic inflammatory diseases while expanding our immunology portfolio," said Kim Taylor, President, Centocor Ortho Biotech. "Importantly, as patient safety remains our top priority, we have collaborated with the FDA to develop a Risk Evaluation and Mitigation Strategy to help ensure the risks of ant-TNF therapy are appropriately managed by doctors prescribing and patients receiving Simponi ."

- here's the release
- read the Bloomberg article

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