Lupin, India’s third-largest drugmaker, said it plans to file two biosimilar drugs Etanercept and Pegfilgrastim in the US market by the fourth quarter of FY20.
Currently, the clinical trials of both the drugs are in advanced stages, said Cyrus Karkaria, President of the Biotechnology division at Lupin.
Etanercept is the biosimilar version of Amgen-Pfizer's Enbrel used to treat five chronic inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, while Pegfilgrastim is a biosimilar of Amgen’s Neulasta used to stimulate the level of neutrophils, a type of white blood cell that gets damaged in cancer patients undergoing chemotherapy.
Enbrel in 2018 had global sales of $7.13 billion, but the sales have been declining due to the entry of biosimilars.
Lupin’s Etanercept was approved in March this year in Japan and launched subsequently. The drug is marketed in Japan by a local partner Nichi-Iko. In the Japanese market, Lupin is competing against the innovator Amgen’s Enbrel and LG-Mochida’s biosimilar.
In Europe, the second-largest market for Etanercept, Lupin is expecting approval in March 2020 and plans to commercialise it by Q1FY21.
US-drug maker Mylan will commercialise Lupin's Etanercept in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia, said a joint statement by the companies.
Lupin is expected to be the third biosimilar company to enter the European market for Etanercept according to Morgan Stanley and can make $200-250 million of gross revenue and $40-50 million of profit factoring in a profit share with Mylan in 2-3 years. Samsung Bioepis and Sandoz, have launched their biosimilar Etanercept versions.
The company has set an aggressive filing time frame for Pegfilgrastim in the US. The company plans to file it in Q4FY20.
Lupin is also developing other biosimilars such as Ranibizumab, Denosumab, Pertuzumab and Aflibercept, which are in various stages of development. The six biosimilars that Lupin is developing have a combined market size of $33 billion.
Lupin, a late entrant to biosimilars, is focusing on developing drugs directly for global markets. With the experience gained with developing Etanercept for global markets, Karkaria said they have learned valuable lessons.
"We are we looking at our projections correctly, what's the market going to be in the next three to four years, can we suffice with what we have? Or what we don't have? The other thing is, is the (clinical) trial asking the right questions or not, and is the clinical trial going to be very relevant for us to get quick approval. So there are constantly things which evolve, and we have to keep following up," Karkaria said.
He also added that along with commercialisation partnerships, the company is open for external financing and co-development models, to save costs.
Lupin has built a world-class biotech facility in Pune, Maharashtra that can produce both biologic drug substance and drug product with both the mammalian and microbial cell-based process line. The facility is cleared by Japanese and European Union drug regulator regulators.
Indian pharmaceutical companies have been betting big on biosimilars for quite a while as they hope to cash in on its potentially large market.
Biosimilars are replicas of biologic drugs that are used to treat different types of cancers and autoimmune diseases. Unlike small-molecule generic drugs which can be chemically synthesized, biosimilars are large protein molecules, which are harder and more expensive to develop as they are made from living cells and have a far more complex chemical structure that is difficult to replicate.
The estimated cost of developing biosimilars for the global markets is $75-250 million while developing traditional non-biologic generics costs about $3-$5 million.
With many biologic drugs becoming off-patent in various countries, Indian drug makers have been investing millions of dollars to get a piece of this market. A Morgan Stanley report says as many as nine biologic drugs have either gone off-patent or will do so by 2025, with combined revenues of $62 billion in 2018.