Boston-based Epirus Bioscience has gotten the green light from regulators to market its Remicade biosimilar in India, teaming up with Ranbaxy to market the Johnson & Johnson analogue next year.
This is the first approval for the 3-year-old company, and will therefore be its first major foray into the international markets. Epirus’ plan from the outset has been to focus on the international biosimilars market, thanks largely to a clearer regulatory path when it comes to biosimilars in countries like Brazil, Russia, China and India.
The drug, which treats a number of inflammatory diseases like rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis, is the first generic version of infliximab to be approved on the Indian market. It’s a lucrative market to tap – Remicade has annual sales of more than $8 billion, with half of that coming from outside of the U.S. The drug will be manufactured in Mumbai, marketed under brand name Infimab.
“We’re entirely focused outside of the U.S. – it’s the most practical, tractable opportunity,” CEO Amit Munshi said.
When the company was ironing out its strategy as a startup a couple years ago, India emerged as the more logical launch market for a Remicade biosimilar, Munshi said, for a very simple reason:
“As a small company two years ago, we were limited in terms of total resources,” Munshi said. “We could have done multiple markets in Latin America or Southeast Asia, for instance, but that’d involve translating all our documents into multiple languages.”
Because biosimilars require fairly comprehensive clinical trials where generics do not, Epirus chose to look for a place where it could run relatively large-scale clinical trials in English, Munshi said. It just completed a Phase 3 trial in India of Infimab, which garnered it approval, and it’s also conducted a Phase 1 in the United Kingdom.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“The U.S. does not have a well-established regulatory framework for biosimilars, but the rest of the world does as a whole,” Munshi said. “At the same time, the bar for getting drugs approved around the world has gone up, and regulators are asking for more and more data – you could argue a bit of a conversion is happening around the world.”
India, of course, is a relatively small market for the Remicade copycat, Munshi said. It’s a 100 percent cash-pay market for a costly drug (Remicade sells for about 70,000 rupees, or $1,150 per month, Reuters says) which makes it a good place to test the waters of international biosimilars.
The company is also developing biosimilars for arthritis drug Humira and cancer drug Avastin, aiming to hit the market right as their patents expire in 2018 and 2020, respectively.
