Epirus's Biosimilar Arthritis Drug Wins Approval In India
By C. Rajan, contributing writer
Boston-based biotech firm, Epirus Biopharmaceuticals, has received final marketing and manufacturing approvals from India’s drug regulators for its Remicade (infliximab) biosimilar, BOW015, making it the first infliximab biosimilar approved in India.
"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," said Amit Munshi, president and CEO of Epirus. "We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets."
BOW015 is a biosimilar to Remicade (Johnson and Johnson), which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn's Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. Munshi estimates that the Indian market for Remicade is worth $8 million to $10 million a year.
Epirus plans to launch the Remicade biosimilar in India through its Indian partner, Ranbaxy, under the brand name Infimab in early 2015. BOW015 will be manufactured by Reliance Life Sciences at an approved facility in Mumbai.
In January this year, Epirus signed a licensing agreement with Ranbaxy, a subsidiary of Sun Pharma/Daichii Sankyo, under which Epirus is responsible for the development and supply of BOW015, while Ranbaxy will register and commercialize BOW015 in India and a few other markets in Southeast Asia and North Africa. Epirus is also looking to gain marketing approvals for this biosimilar in other regions through its partnership with Ranbaxy and other drug makers.
Epirus recently demonstrated the comparability of BOW015 to Remicade in Phase 3 clinical trials in severe rheumatoid arthritis (RA) patients. Epirus also plans to launch an additional Phase 3 trial in Europe in early 2015.
Biosimilars, also known as copycat drugs, are becoming increasingly popular as patents of many older blockbuster drugs are set to expire in this decade. The global market for biosimilars was $1.2 billion last year and is estimated to rise to $24 billion in 2019.
Epirus is one of the many biotech companies focused on developing biosimilars, and its pipeline of biosimilar product candidates includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030 (bevacizumab). According to the company’s press release, the three brand name drugs together generated $26.2 billion in global sales in 2013.
In related news, Ranbaxy will also be selling the cheaper version of Gilead’s hepatitis C drug, Sovaldi in India. Gilead recently licensed Sovaldi to seven Indian firms for a much cheaper price tag in an effort to help treat the millions of hepatitis C patients in developing countries.