PUNE: Drug major Lupin said its joint venture with Japanese firm Yoshindo, YL Biologics, has completed global phase III trials of its Etanercept biosimilar which has met successful outcome for rheumatoid arthritis.
The randomized trial of 52 weeks was conducted in 11 countries and included over 500 patients, Lupin said.
The biosimilar YLB 113’s efficacy and safety were compared against Amgen and Pfizer’s Enbrel which has a global market of USD 11 billion as per IQVIA MAT Q3 2017 data, it added.
Lupin MD Nilesh Gupta told PTI: “Biosimilars are a big part of the generic story going forward. The successful completion of our Phase III trial of Etanercept biosimilar marks an important milestone in our biologics journey.”
This helps us put together a robust regulatory dossier intended for global regulatory filings for YLB113, he added.
“We currently have multiple high-value biosimilar candidates in our late-stage global development pipeline. We remain committed to advancing our biotech R&D capabilities so that more patients across the world can access affordable, high-quality biosimilars,” Gupta said.
The study was conducted at 110 rheumatology clinics across Japan, Europe, and India. This study included over 260 Japanese patients from 62 rheumatology clinics, the statement said.
Lupin Biotechnology Division President Cyrus Karkaria said: “We will be filing for the regulatory approval for YLB 113 in Q1 of FY 19 in Japan and EU and by Q1 or Q2 of FY 19 in India.”
In the US market it would be later, maybe one or one and a half year after that, he added.
Lupin has a pipeline of 7 biosimilars with a target market size of USD 24 billion and the key products include Ranibizumab and Pegfilgrastim, Karkaria said.
On investments, he said that the company has already invested Rs 1,500 crore would invest more if required.