Product differentiation, global partners, and a large suite of biosimilars in development are ways that Reykjavik, Iceland-based Alvotech expects to stay ahead of the competition.
The Center for Biosimilars® Senior Editor Tony Hagen interviews Anil Okay, chief commercial officer for Reykjavik, Iceland-based company Alvotech, which is developing multiple biosimilars in-house and forming global partnerships to market these agents once they receive regulatory approval and clear legal hurdles. Alvotech is also notable for its attempts to bring a high-concentration form of adalimumab (AVT02) to market in the United States and the European Union.
Okay explains he considers citrate-free, high-concentration adalimumab to be a superior product to lower-concentration forms, and he expresses doubts about the strength of the market for these products in 2023, when as many as 6 lower-strength adalimumab biosimilars will launch.
Although Celltrion Healthcare (Incheon, Republic of Korea) aims to begin marketing its high-concentration adalimumab biosimilar (Yuflyma) in the European Union this year, Alvotech hopes to become the first to market a high concentration adalimumab biosimilar in the United States, Okay says.
He also discusses Alvotech’s intentions to obtain an interchangeable designation in the United States for AVT02, which would facilitate substitution of AVT02 for the reference product (Humira) at the pharmacy counter.
Interchangeable designations require additional hurdles for FDA approval, but obtaining one is a marketing advantage and it’s likely a much faster route than waiting for the FDA to relax its policy on interchangeable requirements, Okay says, adding that interchangeability will resonate with end users. “It works at the end because it increases the uptake. It increases the confidence of the decision makers to switch to your product.”
Alvotech still must duke it out with Humira originator AbbVie over opposing lawsuits over high-concentration adalimumab biosimilar. These may delay market entry for AVT02.
Okay discusses Alvotech’s plans to broaden its slate of biosimilars for immunology and enter the primary care field of biologics, and he explains that Alvotech is somewhat hesitant to bring more biosimilars to the oncology sector given the rapid pace of drug development and the financial risk that newer, more powerful agents may emerge and displace products upon which biosimilars are based.
He also discusses Alvotech’s investment in bringing biosimilars to the China market, which currently is emerging yet dominated by local producers and developers, so much so that Pfizer recently backed out of a $350 million factory investment in Guangzhou. Alvotech is partnering with local, well-established companies in China that Okay believes will employ their resources to successfully market Alvotech’s biosimilars.
The company is repeating this partnership formula in other markets across the globe, such as Brazil and Saudi Arabia, to gain footholds in distant markets.
A further marketing strategy Okay talks about is the development of automatic injectors to enhance the convenience of biologics administration and gain market share.“We believe nonprice attributes are equally important to differentiate our products in the market.”