Lupin eyes European market next for its biosimilar bet

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Europe will be the next big market for drug maker Lupin’s biosimilar strategy. The pharma major has been betting big on its biosimilar pipeline and expects to launch Etanercept biosimilar in Europe by July next year.

“We already have API & drug facility approval from the European Medicines Agency and expecting final approvals by March 2020. We expect to get pricing approvals, etc. and launch Etanercept in Europe by July 2020,” says Cyrus Karkaria, President – Biosimilars, Lupin Ltd.

Etanercept, referencing the brand-name Enbrel, is used to treat certain types of auto-immune diseases. The innovator drug did global sales of over $11 billion in 2017.

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The company says it is confident of a good run in Europe owing to limited competition in the market. Lupin will be the third player in the European market after rivals Sandoz and Samsung Bioepis, who have together already done sales inching up to a billion dollars. Lupin has an Etanercept marketing deal with US drugmaker Mylan for Europe, Australia, New Zealand and Asia.

Europe will be the second regulated market for Lupin’s Etanercept. The company has already launched it the Japanese market with its collaborator Japan’s Nichi-Iko, as part of its commercialization, promotion and sales deal for the drug.

“It is too early to assess our product’s performance in Japan but looking at our competitors’ growth we are optimistic to garner a good market share in the coming year,” Karkaria added.

But the biggest market for Lupin’s Etanercept foray is going to be the US, for which the company is undertaking US-centric clinical trials and says it will be able to file its application with the USFDA by Q4 FY2020.

The changing landscape in the world’s biggest pharma market has made many drug majors relook at their biosimilar pipeline and strategy. Lupin, however, says it is tuned in to the market opportunities and does not feel the need to reevaluate its strategy.

USFDA’s latest guidelines on interchangeability for biotech products is touted to be game-changer for biosimilar players and Karkaria says the company is evaluating the prospects for Etanercept.

USFDA’s guidelines say biosimilars can achieve an interchangeable status, which means they may be substituted for the reference biologic without a prescriber intervening. But this requires extensive clinical studies after original trials to establish biosimilarity.

“USFDA’s interchangeability guidelines on Biosimilars will be beneficial for generic cos, particularly self-administered products like Etanercept. However, so far no biotech product has gone through interchangeability trials. Once FDA ratifies it we will evaluate our position. We are currently assessing the market opportunity as interchangeability is needed at the pharmacy level and not at the payer level.”

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow