Sandoz Takes Aim at AbbVie's Humira with FDA Acceptance of Biosimilar Application

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With less than one year to go until AbbVie’s blockbuster drug Humira loses patent protection in the United States, a number of biosimilar treatments are waiting to hit the market. Sandoz hopes its high-concentration formulation (HCF) of an already greenlit biosimilar will be approved by the time of the patent fall.

A high concentration formulation of Humira was approved in the U.S. in 2015. On Thursday morning, Sandoz, the generics and biosimilars unit of Novartis, announced the U.S. Food and Drug Administration had accepted a supplemental Biologics License Application for a high-concentration formula of Hyrimoz (adalimumab-adaz), an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions. 

Sandoz said the application includes indications for Humira that are not protected by orphan exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

Keren Haruvi, president of Sandoz and head of North American operations, said biosimilars play a crucial role in healthcare. The drugs provide the same level of protection as the reference drug but at significant savings.

“Should the Hyrimoz HCF be approved, we believe this important biosimilar medicine would help expand access to more patients with serious inflammatory diseases, including those who currently may not have access to it,” Haruvi said.

Hyrimoz was first approved by the FDA in 2018. However, all other Humira biosimilars approved for use in the United States will not be available for commercialization until July 1, 2023.

AbbVie has been highly protective of Humira, which has remained the world’s best-selling drug since 2012. Humira has generated more than $20 billion for the Illinois-based company. In order to protect that revenue stream, AbbVie protected it with a thicket of patents.

In late 2018, Humira began to face biosimilar competition in Europe per deals AbbVie struck to protect its cash cow. Among those challengers is the initial formulation of Hyrimoz, and the European Medicines Agency recently accepted the application for the proposed HCF for Hyrimoz.

Biosimilars are biologic products that are highly similar to a branded drug but are uniquely different in composition. That differentiates biosimilars from generic drugs, which are exact chemical replicas of other drugs. Biosimilar drugs have been widely available in Europe since 2006, but the FDA only granted the right to review and approve them when the Affordable Care Act was passed in 2010. The first biosimilar to receive approval in the U.S. was Sandoz' Zarxio, which was approved in 2015. Zarxio is a biosimilar to Amgen’s Neupogen, a bone marrow stimulant for post-chemotherapy patients.

There have been multiple biosimilars to Humira approved by the FDA. Among those are Coherus Biosciences’ Yusimry, approved in 2021 and Pfizer’s Abrilada, which was approved in 2019. 

Hyrimoz has been in use across the globe for several years. Sandoz touted “more than 65 million days of patient experience” with the current formulation. If the HCF is approved, the company said it will be its first in the U.S. for this disease space.

Prior to submitting the sBLA to the FDA, Sandoz conducted a Phase I pharmacokinetics bridging study that compared the original formulation of Hyrimoz to the high concentration formula. The study met all of its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the two formulas, the company said.