Etanercept, already approved in the US, is used to treat inflammatory conditions.
It is pending approval in Japan and Europe. According to Lupin, the non-US market for Etanercept is estimated at USD 4 billion.
The indications targeted for approval in Japan are Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Axial spondyloarthritis, Non-radiographic Axial Spondyloarthritis and Plaque Psoriasis.
Lupin’s Japanese subsidiary Kyowa had submitted a marketing application for the drug in Japan in March this year, following the conclusion of its global Phase III study.
The trial, which compared the drug’s efficacy and safety directly against Enbrel of Amgen/Pfizer, was conducted at 110 rheumatology clinics across Japan, Europe and India.
“This study included over 260 Japanese patients from 62 rheumatology clinics, a scale that is unique for a global RA trial for Japan,” Lupin said.
Lupin’s MD Nilesh Gupta called the drug a key product in its biosimilars and complex generics strategy.
“Our partnership with Nichi-Iko,takes us a step closer to the launch of our first in-house developed biosimilarthat is used to combat a range of severe autoimmune disorders,” Gupta said.
Biologics are a fast-growing area of the global pharma business.
Unlike regular drugs, which are typically produced via chemical synthesis, biologics are manufactured in a living system such as a microorganism, or plant or animal cells and are usually far more complex in their molecular structure than typical drugs.
Gupta said the market for biologics in Japan is expected to reach US$13.5 Bn next year.
“The successful commercialization of our first biosimilar will help our foray into the fast-growing biologics space and also provide patients in Japan access to a high quality affordable alternative.”
The drug was developed by YL Biologics, a joint venture between Lupin’s subsidiary Lupin Atlantis Holdings SA (LAHSA) and Yoshindo.
Nichi-Iko already has a biosimilar in the Japanese market called infliximab.