SWITZERLAND — Sandoz, the Swiss drugmaker and subsidiary of Novartis, announced on Saturday the release of its biosimilar alternative to AbbVie Inc’s highly popular arthritis medication, Humira.
The introduction of Sandoz’s drug, named Hyrimoz, further intensifies the competition for Humira in the United States, a competition that began in January.
Hyrimoz will be priced at a 5% discount off Humira’s current list price of US$6,922 per month. Additionally, Sandoz is offering an unbranded version of Humira at a significant 81% discount.
This pricing strategy aims to attract pharmacy benefit managers, who negotiate discounts on behalf of their customers, such as large employers and health insurance plans.
By offering lower-priced options, Sandoz hopes to appeal to healthcare systems that serve as both insurers and providers and typically do not seek after-market discounts like pharmacy benefit managers.
Biosimilars, unlike traditional generic drugs, are designed to mimic the original branded biotech drug but may not be exact copies due to the use of living cells in their cultivation.
Amgen Inc was the first to launch a biosimilar version of Humira earlier this year, with discounts ranging from 5% to 55% depending on the purchaser.
By the end of this year, it is anticipated that at least nine different companies, including Pfizer Inc and South Korea’s Celltrion, will offer biosimilar alternatives to Humira in the United States.
The entry of biosimilars into the market comes after AbbVie’s extended monopoly, during which the company generated approximately US$96 billion in additional Humira sales in the United States from 2017 through the first quarter of 2023.
To delay the entry of biosimilars, AbbVie employed an aggressive patent-thicketing strategy, primarily focusing on methods of manufacturing and administering the drug rather than the drug itself. This litigation campaign successfully delayed the introduction of Humira biosimilars.
Biosimilars are expected to provide significant cost savings to insurance companies, governments, and patients, as they offer similar clinical outcomes to the brand-name biologics they reference.
The U.S. biosimilars market has witnessed numerous approvals and launches, with at least 41 approvals and 30 launches recorded as of May 25.
According to a report by AmeriSourceBergen, as the market continues to mature, its pipeline of biosimilars continues to grow.
The growing demand for biologics coupled with the impending expiration of exclusivity for over 55 blockbuster drugs with peak sales exceeding US$1 billion has positioned the biosimilars market for substantial growth.
In an article by McKinsey & Co., it was projected that by 2030, the global biosimilars market could reach a value of US$74 billion, more than triple the value at the time of the report.
Navigating patent thickets in the biosimilars market
AbbVie’s extensive patent portfolio enabled the company to maximize its profits and delay the entry of biosimilar competitors.
Through strategic lawsuits and settlements, AbbVie allowed biosimilar entry on terms favorable to itself, avoiding the expiration of its patents.
The biosimilars market is poised for significant growth as numerous blockbuster brands face the loss of exclusivity.
McKinsey predicts that 19 global blockbusters will lose exclusivity by 2025, with an acceleration from 2026 to 2032, when 39 more blockbusters are expected to lose exclusivity. Among these are five “megabrands” with annual sales exceeding US$10 billion.
Compared to the Hatch-Waxman Act for traditional generic drugs, lawsuits under the Biologics Price Competition and Innovation Act do not automatically trigger a 30-month stay on FDA approval for biosimilars.
Instead, patent holders must demonstrate a “likelihood of success on the merits” in district court to secure a delay, while accused infringers must prove a likelihood of prevailing in invalidating the patents or showing non-infringement.
This standard often encourages settlements before a ruling that could hinder either party’s strategy.
Amgen has achieved notable success in biosimilar patent litigation, being the first to launch a biosimilar version of Humira, called Amjevita.
It gained a five-month head start over competitors, including Organon & Co., whose Hadlima, manufactured by Samsung Bioepis Co., was poised to be available in the US from July 1.
Several other Humira biosimilars are also set to launch on the same day, with more expected later this year.
In May, Amgen settled a patent infringement lawsuit with Janssen Biotech Inc. over a proposed biosimilar of the ulcerative colitis drug Stelara.
The settlement came shortly after J&J sought a preliminary injunction based on patents initially not asserted in the case, but acquired through the acquisition of Momenta Pharmaceuticals Inc.
This strategic move allowed J&J to protect its key Stelara patent set to expire in September, ultimately influencing Amgen’s decision.
Navigating patent thickets remains a critical challenge in the biosimilars market, with companies employing various strategies to defend their market position and delay competition.
As the biosimilars market continues to evolve, the balance between innovation and accessibility to affordable treatments will shape the future of the industry.
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