The latest issue of Generics bulletin, an international trade magazine, which covers news in the global generic medicines and biosimilars markets with subscribers in over 60 countries, features an in-depth article on Alvotech’s new state-of-the-art facility in Reykjavik. The piece discusses how the company has fulfilled its vertically-integrated vision a mere three years after its foundation.
In an exclusive interview with Generics bulletin during the facility’s inauguration, the CEO of Alvogen and the founder of Alvotech, Robert Wessman, and Alvotech’s CEO, Eef Schimmelpennink, outlined how the company intended to take a unique path to becoming a leading, global biosimilars player.
Noting that the Reykjavik plant would have 16,000 litres of fermentation capacity through a mix of 1,000- litre and 2,000-litre bioreactors employing disposable, single-use bags, Wessman said the facility would provide capacity for Alvotech’s “first four or five products” through to around 2025. An empty plot on the site would provide ample room for expansion, he added.
Following extensive interaction with regulators, Schimmelpennink continued, Alvotech would pursue inspections of the Reykjavik facility in two phases. “First, the plant will undergo an engineering inspection. And then in mid 2017, we will seek a good manufacturing practice (GMP) licence,” he revealed. Clinical-batch production was scheduled for midway through next year, with “commercial production tied to loss of exclusivity from around 2019 and 2020”.
“We really did build for the future,” Wessman stated, pointing out that the facility could fill and finish up to 3 million units per year. Few companies, he stressed, could match Alvotech in having all functions from cell-line development through product development and analysis to API and finished-dose production.
Schimmelpennink added that controlling a vertically integrated facility would ensure that Alvotech was not subject to the complexities and often lengthy lead times involved with working with a contract manufacturer. The firm, he said, would be better placed to react quickly to fluctuations in demand.