Feb. 11--A copy of a popular arthritis drug is one step closer to receiving regulatory approval, which could bring some financial relief to patients.
Celltrion, a South Korean company, has developed a knockoff of Johnson Johnson's Remicade, which is used to treat autoimmune conditions such as rheumatoid arthritis, chronic inflammation of the digestive tract and plaque psoriasis. An advisory panel to the Food and Drug Administration voted this week to recommend the agency approve the sale of the copy, known as a biosimilar.
A final FDA decision is expected in April, said Celltrion, which has licensed the drug to Pfizer for sale in the United States. Pfizer inherited the license when it acquired Lake Forest-based Hospira last year.
Pharmaceutical industry analysts expect Pfizer to sell the drug, to be sold under the brand name Inflectra, at a discount to Remicade and similar biotech drugs used to treat autoimmune diseases.
A single dose of Remicade can cost from $1,300 to $2,500. Rebate programs are available to help insured patients cover out-of-pocket costs.
One of Remicade's competitors is Humira, sold by North Chicago-based AbbVie. Humira had sales of $14 billion last year, making it one of the world's best-selling medicines.
AbbVie and other drug companies are aggressively looking at their legal options to block copies from entering the U.S. market. AbbVie, for instance, has built up an arsenal of 70 patents to protect Humira's sales. The primary patent on Humira's molecular composition is due to expire in December.
asachdev@tribpub.com
