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

April 18, 2019
The Center for Biosimilars Staff

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

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.