On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies with products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight the European manufacturer Alvotech. The drug maker has its main headquarters and manufacturing facility in Reykjavik, Iceland, with other centers in Germany, Switzerland, and in the United States.
Established in 2013 by its current Chairman, Robert Wessman, Alvotech exists to develop and produce biosimilars. Mr. Wessman also founded the generic manufacturer Alvogen, which is based in New Jersey (and founded in 2009). Alvotech does not currently have any marketed proprietary agents. However, it does promote its contract biologic manufacturing capabilities.
Why you may be hearing more about this company: Alvotech has just signed a commercialization agreement with Teva for its entire pipeline of six biosimilars. The lead product seems to be a biosimilar of adalimumab (AVT-02), and this agent was the subject of 6 clinical trials. Alvotech’s website does not list the other biosimilars in its pipeline, and none of the others seem to be in early-stage clinical trials. The phase 1 and 3 trials of AVT-02 seem to be completed. The Alvotech/Teva partnership gives Teva a stake in a crowded adalimumab biosimilar field (seven adalimumab biosimilars already licensed by AbbVie to launch in 2023). We assume that Alvotech will also join the licensing queue with AbbVie in order to launch in 2023.
In other biosimilar news…Pfizer’s Inflectra® sales, though generally considered “anemic” in the US at only a 10% marketshare, have actually outearned EU sales of the drug. Ronny Gal, PhD, of Bernstein Research was quoted in FiercePharma, explaining that Inflectra holds 30% of the EU market but only earned second-quarter 2020 revenues of $116 million, because it sells at a much lower price than in the US. In comparison, second-quarter US sales were $158 million. To put this into some perspective, that means annualized sales of more than $500 million, which would more than cover its research and development costs, despite the poor market penetration.