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.”
BioRationality: Biosimilar Associations and Stakeholders Representing Biosimilars
January 20th 2025Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars Drive Cost Savings and Achieve 53% Market Share Across Treatment Areas
January 16th 2025Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Cost-Efficiency in Action: Denmark's Transition to Biosimilar Adalimumab
January 14th 2025The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.
The Next Frontier: Oncology Biosimilars in 2025 and Beyond
January 13th 2025The US oncology biosimilar market has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.