HONG KONG – Lupin Ltd. and Mylan NV will be working together on commercializing a biosimilar Enbrel (etanercept) drug, or YLB-113, in a deal that brings Lupin an up-front payment of $15 million and potential commercial milestones together with an equal share in net profits of the product.

Rajiv Malik, president of Mylan, hailed the collaboration with Lupin as "yet another positive step" in the firm's ongoing efforts to bring key biosimilars, like etanercept, to patients around the world. "We look forward to working closely with Lupin to commercialize their etanercept biosimilar and reach patients in Europe, Australia, New Zealand, Latin America, Africa and most Asian markets," said Malik.

A Lupin spokesperson told BioWorld that the Indian company retains the rights to the biosimilar in India, the Philippines, Myanmar and Vietnam. Mylan's deal in Asia will only cover China and other markets.

"Mylan is well-positioned to commercialize our etanercept biosimilar given their significant expertise and global infrastructure," said Vinita Gupta, CEO of Lupin. "This partnership enables us to accelerate our etanercept market plans across multiple regions globally, as we continue to advance our pipeline of biosimilar candidates."

Etanercept is a TNF inhibitor for the treatment of certain autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Lupin successfully completed its etanercept biosimilar phase III trial in February. The study was a multinational, randomized, double-blind, controlled trial of 52 weeks duration, which included more than 500 patients with rheumatoid arthritis. It compared the efficacy and safety of Lupin's YLB-113 directly against Amgen Inc.'s Enbrel. The study was conducted at 110 rheumatology clinics across Japan, Europe and India.

Included in the study were more than 260 Japanese patients from 62 rheumatology clinics, a scale that is distinct for a global rheumatoid arthritis trial in Japan.

In Japan, Lupin recently sealed a deal for the distribution, promotion and sale of YLB-113 with Nichi-Iko Pharmaceutical Co. Ltd.

According to Nilesh Gupta, managing director of Lupin, YLB-113 is the Mumbai-based company's first biosimilar. It was developed by developed by YL Biologics Ltd., a joint venture between Lupin's subsidiary, Lupin Atlantis Holdings SA (LAHSA), and Yoshindo Inc.

The product will be launched by Nichi-Iko after receiving approval from Japan's PMDA.

"Given the market evolution and the market size, Lupin is focused on building its complex generic and biosimilar portfolio in addition to building a meaningful branded specialty business. The first foray into biosimilars is with etanercept," Nilesh Gupta told BioWorld.

"This is part of a core strategy that we started executing on more than six years ago," he added. "We believe that exclusive products and complex generics is where the future lies. We are also excited with the way the market for biosimilars is developing, and the regulatory pathway is much clearer now than ever. Importantly, there is a lot more clarity in commercializing biosimilars now than ever before."

Nilesh Gupta said Lupin is eyeing a U.S. filing in 2020.

Lupin estimates that the market for biologics in Japan is expected to reach $13.5 billion next year. And etanercept seems to be one of the leading drugs in that space. According to pharma consulting company Iqvia, Enbrel had global brand sales of approximately $11.6 billion for the 12 months ending Dec. 31.

The addition of a biosimilar with such strong sales potential is also great for companies like Mylan.

According to a report by Zacks Equity Research, Mylan has one of the widest portfolios of generics and biosimilars, and the addition of a biosimilar Enbrel is expected to further boost the company's portfolio. The company recently got U.S. FDA approval for its biosimilar Neulasta (pegfilgrastim, Amgen Inc.), Fulphila. The company earlier won an approval for Ogivri, its biosimilar of Roche Holding AG's Herceptin (trastuzumab).

The triumph of Mylan's biosimilar products could help ease the pressure on its generics business, which has hit a bit of a bump.

Mylan's stock took a hit earlier in the month after the company announced that the FDA would not approve its abbreviated NDA for its generic version of Glaxosmithkline plc's asthma drug, Advair Diskus, yet again. Mylan said the complete response letter identified minor deficiencies.

The Zacks report said Mylan has more than 30 submissions planned in 2018.