Eye on Pharma: Fuji Pharma to Sell Alvotech's Biosimilar Ustekinumab in Japan

Fuji Pharma will market Alvotech’s biosimilar ustekinumab in Japan, the companies announced this month.

Alvotech will receive an upfront payment of $4.6 million as a part of the transaction, with rights to receive total milestone payments up to $20 million. Alvotech will assume responsibility for full development and commercial supply out of its new manufacturing facility in Reykjavik, Iceland.

The agreement comes a few months after Fuji Pharma recently agreed to invest $50 million in Alvotech.

Ustekinumab references Janssen pharmaceuticals’ Stelara, which is approved to treat plaque psoriasis, psoriatic arthritis and Crohn disease. Johnson & Johnson, Janssen’s parent company, reported that, last year, Stelara generated approximately $5.2 billion worldwide in net revenues.

Alvotech‘s initial pipeline consists of 6 biosimilar monoclonal antibodies and fusion proteins aimed at treating severe immune, inflammatory conditions.

In Japan, there are 8 biosimilars currently approved, including 1 insulin glargine. Of the remaining products, 3 are biosimilar filgrastim products (of which 1 is developed by Fuji Pharma), 1 is a biosimilar infliximab, 1 is a biosimilar somatropin, and 1 is a biosimilar epoetin alfa. In addition, late last year Daiichi Sankyo announced that it launched its biosimilar trastuzumab, trastuzumab BS, referencing Herceptin.

Last month, Alvotech started enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira.