|Ranbaxy's global headquarters, Gurgaon, India--Courtesy of Ranbaxy|
The biosimilar bonanza is underway, and Johnson & Johnson's ($JNJ) rheumatoid arthritis (RA) drug Remicade is at the center of the copycat action. Boston-based biosimilar maker Epirus Biopharmaceuticals is rolling out a knockoff of the monoclonal antibody (mAb) in India with partner Ranbaxy Laboratories, a year after Hospira got its Remicade version approved in Europe.
Epirus said today that the drug, its first, is coming to market in India a quarter ahead of schedule. It will be manufactured by Reliance Life Sciences at a facility in Mumbai and sold at a discount to the price of Remicade.
"It will be available in India at a very significant discount as compared to the innovator drug," Ranbaxy Vice President Rajeev Sibal, said when it was announced at the Indian Rheumatology Association Conference today, Pharmabiz.com reported. "More Indian patients will get the benefit of a world-class biologic treatment."
It is no surprise that Remicade is one of the drugs that biosimilar makers most want to copy. It ranks third on the FiercePharma list of top-selling drugs for 2013, with global sales of $8.4 billion. Johnson & Johnson's Janssen earns most of that, $5.2 billion, with partners Merck and Mitsubishi Tanabe Pharma sharing the rest of the spoils. The company did not respond to a request for a comment.
The popular treatment for the debilitating effects of rheumatoid arthritis doesn't go off patent in the U.S. until 2018 but IP protection has lapsed elsewhere. Hospira ($HSP) and its biosimilar partner South Korea-based Celltrion got their versions, Inflectra and Remsima, approved last year in Europe, a milestone since it was the first mAb biosimilar to be approved in the EU.
This is the second biosimilar to be launched in India. In February, Mylan ($MYL) and partner Biocon launched a copy of Roche's ($RHHBY) cancer drug Herceptin, also among the top 10 best-selling drugs of last year.
A number of other top-selling biologics come off patent in the next 5 years, including Humalog, MabThera and Aranesp. Many of these are blockbusters and have already been targeted by companies hoping to cash in on worldwide demand for life-extending biologics and the growing frustrations over the prices they command. Because of the complexities of creating biosimilars, they are expected to come at 15% to 30% discounts, rather than the 90% price cuts that often come with small molecule generics. But since so many of the priciest drugs are biologics, they still represent a potential windfall for biosimilar makers and payers.
Epirus intends to be among those. The company earlier this year raised $36 million for its work on its Remicade knockoff, as well as follow-up programs for Humira and Avastin.
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Special Report: The top 10 best-selling drugs of 2013 - Remicade - Herceptin