In a first for both the country and the company, the Drug Controller General of India approved Epirus Biopharmaceuticals Inc.'s infliximab biosimilar.

Besides being the first biosimilar to Johnson & Johnson's Remicade approved in India, the Epirus drug, to be marketed as Infimab, is among the first drugs developed for the Indian market in accordance with the country's 2012 biosimilar guidance, which raised the bar for follow-on biologics. It also is the first approval anywhere for the Boston-based Epirus.

Infimab, formerly known as BOW015, will be manufactured by Epirus partner Reliance Life Sciences at its facility in Mumbai and will be commercialized in India by Ranbaxy Laboratories Ltd. The partners plan to launch the drug by the end of the year, Epirus CEO and President Amit Munshi told BioWorld Asia.

In the meantime, they are working through distribution issues and laying out a pricing strategy that will ensure Infimab is a profitable brand and yet accessible to Indian patients who generally pay for health care out of pocket in the private sector.

Unlike other partnerships that have resulted in a biosimilar being commercialized under each partner's brand in the same market, Munshi said that, to eliminate confusion, BOW015 will be sold only under the Ranbaxy brand in India.

"Commercializing these molecules is not trivial," he said, noting the extensive education that must take place on the ground. Since Remicade has not been widely prescribed in India, Ranbaxy will have to expand the market base by educating doctors and patients on the use of infliximab to treat inflammatory diseases including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

Commercialization also will involve screening patients, setting realistic expectations and addressing payer dynamics, Munshi said. He expects Epirus will learn a lot about commercialization as Infimab launches in India.

The lessons learned will be useful as Epirus and its partners seek approval for the infliximab biosimilar in other markets. Under a licensing agreement earlier this year, Ranbaxy will register and commercialize the infliximab biosimilar in other territories in Southeast Asia, North Africa and selected other markets. Most of the markets involved are similar to India in that the innovator has had limited penetration and government coverage of health care is minimal, Munshi said. (See BioWorld Today, Jan. 15, 2014.)

EXPANSION PLANS

Epirus is taking a different tack to break into markets such as Brazil and China where health care is covered through government tenders and domestic manufacturing is required or heavily encouraged. Its parnerships in those markets will include technology transfers to ensure the biosimilar will be manufactured domestically in compliance with international standards.

The U.S. biotech partnered last year with Orygen Biotecnologia Ltda. to register BOW015 in Brazil and develop other biosimilars for that market. As part of that deal, Orygen was to have exclusive rights in Brazil, and Epirus agreed to transfer the manufacturing technology for BOW015 to the Brazilian firm. However, Epirus is no longer in that deal, according to the company. (See BioWorld Today, Oct. 23, 2013.)

For all of these markets, Epirus intends to use the dossier it submitted for approval in India. It consists of results from a phase I trial conducted in the UK in accordance with the Medicines and Healthcare Products Regulatory Agency's standards and from a trial in India. Epirus will add to that data with a phase III trial that it plans to initiate next year in Europe.

That trial could support approval in the EU, where the Epirus biosimilar would have to compete with Celltrion Inc.'s Remsima (infliximab), as well as Remicade. Remsima also is approved as a biosimilar in Canada, Japan and South Korea, and has been submitted for review in the U.S. Partnered with Hospira Inc. in Canada and the EU, the Celltrion drug is sold under Hospira's brand, Inflectra, in those markets as well. (See BioWorld Today, Sept. 11, 2013.)

While Epirus is gearing up for global competition, it's staying out of its home market. "The lines are much more clear outside the U.S.," Munshi said, referring to the regulatory and patent landscapes. Commercialization also is much clearer outside the U.S., he added.

Besides expanding the market for its infliximab biosimilar, Epirus is working on biosimilars to adalimumab (Humira, Abbvie Inc.) and bevacizumab (Avastin, Genentech Inc.), which it wants to have ready when the patents for those biologics expire outside the U.S.

Unlike Celltrion, which has been challenging J&J's infliximab patents in several countries, Epirus is taking a more conservative approach. It will wait for patents to expire in a market before it launches a biosimilar. Given the size of Epirus, "it's not in our best interest to get embroiled in any complex litigation," Munshi said. (See BioWorld Today, April 3, 2014.)

Considered a small company, Epirus (NASDAQ:EPRS) recently went public with an all-stock takeover of Zalicus Inc. Its shares closed Monday at $8.55, down 12 cents. (See BioWorld Today, April 17, 2014.)