Lupin submits new drug application to sell biosimilar Etanercept in Japan

Posted on May 15, 2018

Drug maker Lupin on Tuesday said YL Biologics (YLB) – its joint venture firm with Japanese drug maker Yoshindo – has submitted a New Drug Application (NDA) before Japan’s drug regulator to sell biosimilar of Etanercept for treatment of autoimmune disease Rheumatoid Arthritis.

Autoimmune disease occurs when immune system mistakenly attacks our body.

Biosimilars are identical copies of original biologic drugs that have active properties similar to the reference biological product requiring large clinical trials on patients to establish safety and efficacy before approval by regulatory agencies.

Lupin, India’s second largest drug maker by sales, has been a late entrant to biosimilars and is trying to catch up with its rivals spending millions of dollars on developing biosimilars.

Etanercept – the company’s major biosimilar push is being developed targeting highly regulated markets such as US, Europe and Japan, unlike other Indian drug makers who test waters in India and emerging markets before looking at developed markets.

Etanercept, the biosimilar version of Pfizer’s Enbrel, had global sales of USD 11 billion in 2017.

The ex-US market for Etanercept is estimated at USD 4 billion in Japan and Europe along with other regulated and emerging markets.

“With the application now filed, we are preparing to launch an affordable and high-quality biosimilar for consumers in Japan. This is an encouraging outcome as we make a strategic shift across Lupin to higher complexity products,” said Nilesh Gupta, Managing Director, Lupin.

“After significant investment in our biotechnology R&D division over the years, this is the first biosimilar for regulated markets developed inhouse

at Lupin and the first ever complex fusion protein like etanercept in regulated markets by an India pharmaceutical player,” Cyrus Karkaria, President, Lupin Biotech, said.

Lupin said the filing opens up other key markets like Europe, Canada, Australia, the Middle East, South East Asia and Latin America for this product within the next 12 to 18 months.

Successful trials

In February this year, Lupin announced the successful conclusion of its global Phase Ill study of biosimilar of Etanercept or YLB113.

The study was a multinational randomized double-blind controlled trial of 52 weeks duration which included more than 500 patients with rheumatoid arthritis in 11 countries. It compared YLB113’s efficacy and safety directly against Pfizer’s Enbrel.

The study was conducted at 110 rheumatology clinics across Japan, Europe and India. This study included over 260 Japanese patients from 62 rheumatology clinics.

Lupin further added that it is on course with its plans for filing in the US and is targeting a filing in FY 2019-20.

Shares of Lupin rose 0.10 percent to close at Rs 775.40 on BSE, the benchmark Sensex gained 0.02 percent to end 35,216.32 points.