Epirus, Ranbaxy win India approval for arthritis drug copy

Epirus Biopharmaceuticals

15/09/2014 21:08

By Natalie Grover and Zeba Siddiqui 
    Sept 15 (Reuters) - Epirus Biopharmaceuticals Inc  EPRS.O  
said India's drug regulator has approved its copy of a 
top-selling arthritis treatment, paving the way for its launch 
in the country early next year. 
    The company's Indian partner, Ranbaxy Laboratories Ltd 
 RANB.NS , will sell a copycat version of Johnson & Johnson's 
 JNJ.N  and Merck & Co Inc's  MRK.N  infliximab, an 
anti-inflammatory drug with annual sales of about $6 billion. 
 ID:nBw6YyqsBa  
    The market for copycat biotech drugs, known as biosimilars, 
is becoming more lucrative as patents expire on older, 
high-priced antibody drugs that rank among the pharmaceutical 
industry's biggest sellers. 
    With changing regulations and a looming biotech patent 
cliff, the global market for biosimilars is forecast to rise to 
$24 billion in 2019 from about $1.2 billion last year, according 
to market research firm Frost & Sullivan. (http://bit.ly/1oR6jQf) 
    Infliximab, sold under the brand name Remicade, is used to 
treat rheumatoid arthritis, Crohn's Disease, psoriasis and other 
inflammatory conditions. In India, it sells at about 70,000 
rupees ($1,150) per month. 
    Like its main rivals, Amgen Inc's  AMGN.O  Enbrel and AbbVie 
Inc's  ABBV.N  Humira, the drug works by blocking a protein 
called tumor necrosis factor. 
    Epirus, a Boston-based biopharmaceutical company that 
focuses on developing biosimilar drugs for sale, said it would 
launch the Remicade biosimilar in India under the name Infimab 
by the first quarter of 2015. 
    Chief Executive Amit Munshi, citing various estimates, said 
the Indian market for Remicade was worth $8 million to $10 
million a year. He declined to say how much Infimab would cost 
or to estimate how many patients might use the drug. 
    The drug will be made in Mumbai by India's Reliance Life 
Sciences, part of billionaire Anil Ambani's Reliance Group 
Holdings. 
    Remicade copycats are already being sold elsewhere. South 
Korean drugmaker Celltrion Inc  068270.KQ  won approval in July 
for its version in Japan and is hoping for U.S. approval in 
2015.  ID:nL6N0PF2I4  
    Epirus is also in talks with Ranbaxy, as well as other 
Indian and international companies, about expanding sales of its 
biosimilar drugs in other regions, Munshi told Reuters. 
    "Ranbaxy has, under their license, quite a few markets in 
southeast Asia and North Africa," he said. "We're also working 
with other partners in places like Latin America." 
    Ranbaxy is not the only Indian drugmaker to explore 
production of biosimilar drugs. Dr. Reddy's Laboratories Ltd 
 REDY.NS , for example, is developing biosimilars with Germany's 
Merck KGaA  MRCG.DE . 
    Biocon Ltd  BION.NS  has a tie-up with Mylan Inc  MYL.O , 
while Lupin Ltd  LUPN.NS  has entered a deal to sell a 
biosimilar version of Sanofi SA's  SASY.PA  blockbuster insulin, 
Lantus, in India. 
 
 (Editing by Robin Paxton) 
 ((natalie.grover@thomsonreuters.com)(;)(within U.S. +1 646 223 
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Keywords: EPIRUS BIOSIMILARS/