Lupin steps up focus on biosimilars with an eye on $24 bn global market

Company to build pipeline of seven biosimilars, announces successful outcome of global phase-III trial for Etanercept for rheumatoid arthritis

Lupin will increase increase investments in its biotech business as it looks to build a pipeline of seven biosimilars with a total market size of $24 billion. Biosimilars are copies of innovative biologic drugs and are made from living cells. 

On Wednesday the drug maker announced the successful outcome of global phase III trial for biosimilar Etanercept which is indicated for treatment of rheumatoid arthritis.  

Etanercept is a copy of Amgen's $11 billion drug Enbrel. Lupin is developing the drug in a joint venture partnership with Japanese drug maker Yoshindo. 

“We are working on strategies to invest only as necessary and supplement with external financing and co-development models. With the experience gained with developing Etanercept for global market there are plans to increase the research and development and manufacturing investments in biotech strategic business unit,” said Lupin's biotechnology division president Cyrus Karkaria.

Lupin had tied up with a financial company to fund the research and development of Etanercept.

Karkaria said Japan, Europe, Australia and Canada are immediate focus markets for   biosimilar Etanercept and the company will file for product approval in early FY 2019. “ Additionally we are looking at the US market some time in FY 2020,” he said.

“Currently we have a pipeline of seven products in various stages of development. This includes Etanercept, Ranibizumab, Pegfilgrastim and four other products all of which together have a market size of $24 billion,” he said.

In 2014, Lupin tied up with drug-maker Yoshido to help in clinical trials and commercialisation of biosimilars in the Japanese market. But the company has been slow to hit the market and peers, including Biocon and Intas, already sell their biosimilar drugs in Europe and Japan. Lupin has now stepped up its efforts to develop complex and specialty products.