In 2022, Humira's global sales soared beyond $21 billion. The product is marketed by AbbVie, the world's fifth-largest pharmaceutical company by market capitalization; AbbVie has often found itself at the center of controversy. Particularly concerning its commercial tactics and strategies to curb competition through excessive patenting. In a move highlighting these contentious practices, the U.S. Congress called on AbbVie's CEO to testify in 2021, addressing both concerns.
Humira is a pioneering biologic therapy that plays a key role in managing a wide range of critical autoimmune-related disorders. As a biologic medicine, which are complex molecules produced by living cells, Humira does not face traditional generic competition. Indeed, companies looking to compete in this arena must develop a "biosimilar," analogous to generics in their potential to lower product costs, yet they must navigate considerably more rigorous regulatory and developmental challenges.
Alvotech, a rare biosimilar-only company, in partnership with Teva Pharmaceuticals, the world's largest generics company, is set to transform the market with the introduction of SIMLANDI®, the first high-concentration, interchangeable, citrate-free biosimilar to Humira.
In 2018, AbbVie introduced a high-concentration, citrate-free version of Humira that reduce injection pain and subsequently shifted over 90% of the market to this new form. Furthermore, the concept of interchangeability, a designation granted by the U.S. FDA established to reduce the immunogenicity risk (the risk that the body may create an immune response to the molecule designed to help), allows patients to switch between a biosimilar and its reference drug, like Humira, without a physician's intervention. In 2023, Amjevita®, Amgen's biosimilar to Humira, entered the market as a low-concentration, non-interchangeable form, and a number of similar products have since been launched. Yet, the adoption of biosimilars has remained minimal, sparking concerns over the unrealized savings biosimilars were supposed to bring.
The concerns are not shared in Europe where today, biosimilar versions of Humira currently dominate the market.
Alvotech's 2024 plans include several product launches around the world through various partners, but the forthcoming introduction of SIMLANDI® in the U.S. is in a market that is truly in the spotlight. Concerns over biosimilar penetration have even prompted new bi-partisan legislation introduced in the U.S. Senate recently that aims to boost incentives for biosimilars that would presumably drive increased usage of biosimilars overall thus reducing prescription costs. The bill, introduced by Michael Bennet (D-Colo.) and John Cornyn (R-Texas), is aimed specifically at Medicare Part B, a portion of the U.S. healthcare system that covers the elderly.
"Far too many seniors forgo treatment because they can't afford the high cost of prescription drugs. This legislation would help lower the costs of prescription drugs by expanding access to biosimilars, which offer the same lifesaving benefits without the higher price tag," said Cornyn in the Senators' recent joint press release announcing the bill. The bill has broad support among industries that support biosimilars.
Despite this, Alvotech's product with interchangeability designation to the high-strength form that dominates the Humira market, could increase access to biosimilars in the world's largest market without additional legislation.
When asked about the upcoming launch, CEO of Alvotech, Robert Wessman noted, "We view the launch of SIMLANDI® as a victory for patients suffering from the numerous disease states that Humira treats and those that are either dealing with the burden of high-cost biologic treatments or have limited to no access to them".
According to recent public statements made by Alvotech, the company has indicated that the launch is "imminent" and some believe the potential impact of the launch could have ripple effects across the U.S. healthcare system.
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