- Pfizer announced after markets closed on Monday it will begin shipping Inflectra (infliximab-dyyb) — a biosimilar version of Remicade — to wholesalers in the U.S. in late-November.
- Inflectra, okayed by the U.S. Food and Drug Administration in April, was the second biosimilar to gain U.S. approval and the first copycat version of Johnson & Johnson's blockbuster anti-inflammatory drug Remicade.
- Originally developed by Korea's Celltrion, Inflectra is approved for Crohn's disease, ulcerative colitis, rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis and psoriatic arthritis.
Pfizer says its version of the blockbuster TNF-inhibitor will be sold at a 15% discount to Remicade's whole acquisition cost (WAC), which does not include discounts to payers.
"Biologics have revolutionized the treatment of many life-threatening and chronic diseases. By introducing Inflectra to the U.S. marketplace, Pfizer is helping customers access an additional high quality treatment option that promises greater savings for the healthcare system," said Diem Nguyen, regional president North America of Pfizer Essential Health Business, in a statement.
Janssen, the Johnson & Johnson unit which markets Remicade in the U.S., said it would continue to defend its intellectual property rights for the drug. The company considers Pfizer's commercial plans to be an "at-risk" launch, according to an e-mailed statement.
Biosimilars, unlike generic drugs, are not exact copies of their reference products because of the small discrepancies in manufacturing biological material. While similar in safety and efficacy, the drugs cannot be switched out by a pharmacist and need to be specifically prescribed.
Yet, payers have been keen to have pharma companies bring biosimilars to market, offering a lower cost alternative to high-priced drugs. Unlike generics though, the hefty price of manufacturing means that biosimilars are not likely to be at a steep discount — much like Pfizer pricing the drug at only 15% below Remicade, instead of the 80% to 90% discount often seen with generics.