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16 September 2014Asia

Epirus, Ranbaxy win Indian approval for arthritis drug

Biopharmaceutical company Epirus has said that India’s drug regulator has approved a biosimilar application to produce a version of a popular arthritis treatment drug.

Epirus announced yesterday (September 15) that the drug controller general of India has approved the similar version of Remicade (infliximab) and that it will be sold by Epirus’s Indian partner, Ranbaxy Laboratories, early next year.

Remicade, produced by pharmaceutical companies Johnson & Johnson and Merck, is used to treat rheumatoid arthritis, crohn's disease, psoriasis and other inflammatory conditions.

In India, it sells at about 70,000 rupees ($1,145) per month.

Boston-based Epirus, which focuses on developing biosimilar drugs for sale, said it would launch the Remicade biosimilar in India under the name Infimab before the first quarter of next year.

“With these final clearances, we are now able to deliver a high quality product to patients who may not be able to afford current treatment options,” Amit Munshi, president of Epirus, said in a statement.

“We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets.”

A Biosimilar is as near as you can get to a copy of a biologic. It is similar to a generic drug but for biological products only.

Ranbaxy and Epirus signed a licensing agreement for the Remicade biosimilar in January 2014.

Under the terms of the agreement, Epirus will develop and supply the drug and Ranbaxy will register and commercialise it in India.

In July, LSIPR  reported that the US Food and Drug Administration accepted what was thought to be the first successful biosimilar application in the US since a law was passed introducing them in 2010.

The application was related to Amgen’s Neupogen (filgrastim) drug, used to treat patients with insufficient white blood cells.