Alvotech, Advanz Pharma Extend Partnership for Biosimilars in Europe

Iceland-based Alvotech announced that it will extend its partnership with Advanz Pharma to commercialize 5 new biosimilars across Europe. Under the agreement, Alvotech will be responsible for development and commercial supply and Advanz Pharma will be in charge of registration and commercialization in Europe.

The deal includes a biosimilars for Simponi (golimumab) and Entyvio (vedolizumab) as well as 3 early-stage undisclosed biosimilar candidates. Simponi is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Entyvio is indicated for ulcerative colitis and Crohn disease. According to IQVIA, the current addressable market for the 5 biosimilar candidates is worth upwards of $4 billion.

“We are very excited to extend our existing partnership with Advanz Pharma into additional therapeutic areas. The growth of our collaboration is based on a common vision and commitment to provide better patient access to more affordable biologics,” said Robert Wessman, chairman and CEO of Alvotech.

In February 2023 Alvotech and Advanz Pharma announced that the companies had entered into an exclusive agreement for the commercialization of AVT23, a proposed biosimilar to Xolair (omalizumab). The agreement covers the European Economic Area, the United Kingdom, Switzerland, Canada, Australia, and New Zealand.

“After signing our initial partnership agreement with Advanz earlier this year, we look forward to deepening our relationship and working with Advanz on bringing additional important therapies to market in Europe,” commented Anil Okay, chief commercial officer of Alvotech.

A confirmatory patient study for the golimumab biosimilar (AVT05) is underway, and marked the fifth internally developed portfolio candidate to be dosed in a patient study.

Alvotech Earnings Report

The news comes after Alvotech published its earnings for the first quarter of 2023. During the first 3 months of the year, the company’s revenue increased to $15.9 million, about $15 million more than the same period in 2022 ($0.8 million).

As of March 31, 2023, Alvotech claimed that it had cash and cash equivalents of $115.8 million, excluding $25.2 million of restricted cash. In addition, the company had borrowings of $793.7 million, including $23.0 million of current portion of borrowings.

Cost of product revenue was $39.1 million, which Alvotech said was primarily a result of product revenues for AVT02, the company’s adalimumab biosimilar, in certain European countries and Canada.

Alvotech is also working to address issues with its manufacturing facility that were outlined in an FDA complete response letter for the company’s biologics license application for AVT02. The company is anticipating the FDA to give its final approval decision in late June 2023, in time for a US launch in July 2023.