EMA accepts Sandoz application for Humira biosimilar

NETHERLANDS – The European Medicines Agency (EMA) has accepted Sandoz’s application for regulatory review of Hyrimoz, the company’s high concentration biosimilar of AbbVie’s Humira.

If approved, Hyrimoz would be used for the treatment of all indications covered by Humira, which include autoimmune and inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and uveitis.

Since its launch in the United States in 2003, Humira has remained the top-selling drug of all time. After extensive litigation, AbbVie has entered into settlements with several manufacturers to allow for a 2023 launch of biosimilars.

Sandoz’s biosimilar had been initially approved as a 50-mg/mL formulation, but the latest application submitted is for its higher-concentration 100-mg/mL dose. 

AbbVie, which is poised to become number one pharma by sales in 2028 is banking on Rinvoq and another immunology medicine called Skyrizi to help slow the sales downfall after Humira faces biosimilar rivals in the US beginning in 2023.

The new formulation will also be free from excipient citrates and use the same auto-injector as its predecessor.


Florian Bieber, Global Head of Biopharmaceuticals Development at Sandoz said that “By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical innovation.”

AbbVie, which is poised to become number one pharma by sales in 2028 is banking on Rinvoq and another immunology medicine called Skyrizi to help slow the sales downfall after Humira faces biosimilar rivals in the US beginning in 2023.

Last month, the FDA approved Rinvoqfor patients with active ankylosing spondylitis, a common form of arthritis.

In March, Rinvoq won approval as a treatment for patients with moderately to severely active ulcerative colitis.

Bullishly, AbbVie and Genmab have co-announced promising study results for their lymphoma treatment in April.

Estimates suggest that global sales topped US$15 billion in 2020, representing a compound annual growth rate of 56 percent since 2015, according to McKinsey report.

According to McKinsey’s biosimilars market model, the market is set to continue its double-digit growth, doubling in size to more than US$30 billion by 2025, and over US$60 billion by the end of the decade.

At the same time, after about a decade in the biosimilars business, Amgen is among the top players in the burgeoning field and next year, it’s looking to really make its mark with the first US biosim to AbbVie’s megablockbuster Humira, Fiercepharma reports.

At the 2022 Biotechnology Innovation Organization (BIO) Convention, Amgen presented a preview of its annual trends in biosimilars report.

In an interview, Amgen’s Ian Thompson, senior vice president and general manager of business operations in the US, said that while Europe got off to a faster start in biosimilars, it’s fair to say that “the US has caught up and arguably overtaken [Europe] in the last few years.”

In the eight years since Europe’s first approved biosim in 2008, 15 received approval there. In contrast, in the eight years after the first US biosimilar launch (2015), 36 have been approved and 22 have launched, Amgen’s trends report says.

Looking forward, Amgen is set to launch the first Humira biosimilar in late January 2023. Over the subsequent months, many other biosimilar players are slated to reach the market through their own settlements with AbbVie.

When those competitors launch, Thompson says the Humira biosimilar market will resemble the competition in innovative medicines as each competitor looks to highlight their own advantages.

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