7 companies are rolling out Humira biosimilars

Boehringer Ingelheim, Organon and Samsung Bioepis together, Sandoz, Fresenius Kabi, Celltrion USA, Coherus and Biocon Biologics have released biosimilars of AbbVie's Humira.

As widely expected by the pharmaceutical industry, seven pharmaceutical companies are releasing biosimilars of AbbVie's Humira.

Boehringer Ingelheim's Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Humira (adalimumab), is now commercially available in the United States.

Cyltezo was initially approved as a biosimilar in 2017 for use in multiple chronic inflammatory diseases. Cyltezo was approved as an interchangeable biosimilar in 2021 and is available as a prefilled syringe or as a Cyltezo Pen autoinjector.

“Cyltezo is the first and only FDA-approved interchangeable biosimilar to Humira that is available to the millions of people in the United States living with certain chronic inflammatory diseases,” said Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim. “Cyltezo reinforces our ultimate goal of providing a more affordable and accessible treatment option for this community, and we look forward to seeing the impact it will have across the United States.”

“Biosimilars such as Cyltezo have the potential to increase patient access to critical biologic medicines, which may benefit people living with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis,” said Steven Taylor, president of the Arthritis Foundation. “We applaud the availability of another treatment option for doctors and patients in the United States.”

“The Crohn’s and colitis patient community welcomes adalimumab biosimilars, including Cyltezo, as new options to treat these inflammatory conditions,” said Michael Osso, president and CEO of the Crohn’s & Colitis Foundation. “We look forward to seeing how these medications may improve patient care.”

“For many people living with plaque psoriasis or psoriatic arthritis, finding effective relief from symptoms can be a daily struggle. We’re always happy to have new treatment options that may help reduce the severity of symptoms and improve the quality of life for patients living with this disease,” said Leah Howard, president and CEO of the National Psoriasis Foundation.

Cyletzo is a tumor necrosis factor blocker that is used to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults. It can be used alone, with methotrexate or with certain other medicines; moderate to severe polyarticular juvenile idiopathic arthritis in children 2 years and older. It can be used alone or with methotrexate; psoriatic arthritis in adults. It can be used alone or with certain other medicines.

[Read more: Fresenius Kabi receives FDA approval for Humira biosimilar]

Organon & Co. and Samsung Bioepis are offering Hadlima (adalimumab-bwwd), a biosimilar of Humira (adalimumab).

Consistent with Humira, Hadlima is available in both citrate-free high concentration (100 mg/ml) and citrate-containing low concentration (50 mg/ml) to provide patients with seamless continuity of care.

“As the largest loss-of-exclusivity event in pharmaceutical history, this is a singular moment for the U.S. healthcare system to embrace biosimilars," said Kevin Ali, CEO of Organon. "Every stakeholder should be invested in the success of this market to realize the value biosimilars can create for patients, providers and the U.S. healthcare economy.

Ali added, “The availability of Hadlima, both high and low concentration, marks an important milestone towards expanding treatment options for millions of patients suffering from chronic autoimmune diseases in the United States."

[Read more: Celltrion USA obtains FDA nod for Humira biosimilar]

Hadlima is a tumor necrosis factor blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. Hadlima (a carton including two pre-filled pens or two pre-filled syringes) is available at a list price (wholesale acquisition cost) of $1,038, which represents an 85% discount in comparison to the list price of Humira, in order to enable expanded access to patients.

Samsung Bioepis’s adalimumab biosimilar (also known as SB5, marketed under different brand names ex-U.S.) has been available in 24 markets globally since 2018 and is supported by extensive clinical experience across rheumatologic, dermatologic and gastroenterological conditions.

Sandoz is offering a citrate-free high-concentration formulation of its biosimilar Hyrimoz (adalimumab-adaz) injection.

Hyrimoz HCF (100 mg/ml) is approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.

"This is an important moment for Sandoz and for the millions of patients living with chronic inflammatory diseases in the United States," said Keren Haruvi, president of North America at Sandoz. "With this launch, we are entering the U.S. immunology market and continuing to fulfill our commitment to expand access to important medicines for patients."

Hyrimoz HCF offers a 50% reduction in injection volume compared to the 50 mg/ml concentration and can decrease the number of injections required for people who need at least 80 mg/0.8 ml dosing, the company said, noting that the HCF formulation is citrate free and uses the same auto-injector as Hyrimoz 50 mg/ml, the Sensoready pen, which is designed with patients in mind. The prefilled Sensoready pen is an ergonomic device with a triangular shape, buttonless injection for self-administration and a 360° viewing window for visual feedback.

Fresenius Kabi also announced today the immediate availability of its citrate-free adalimumab biosimilar Idacio (adalimumab-aacf) for use in the treatment of chronic autoimmune diseases for all eligible indications of Humira.

Idacio is available in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector).

“We are thrilled to launch Idacio, our first immunology biosimilar in the United States,” said Ali Ahmed, senior vice president of biosimilars at Fresenius Kabi USA. “Our adalimumab biosimilar forms part of a dedicated pipeline of affordable and high-quality immunology biosimilars from Fresenius Kabi, aimed to improve the quality of life of patients with chronic diseases.” 

Celltrion USA is another manufacturer that has launched a Humira biosimilar. The company is offering Yuflyma (adalimumab-aaty), a high-concentration (100 mg/ml) and citrate-free formulation. 

Yuflyma is indicated for the treatment of eight conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa.

Yuflyma is listed at $6,576.50 per month. Yuflyma is available in two device types — auto-injector and pre-filled syringe options.

More than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation, the company said, noting that Yuflyma is a citrate-free formulation that is highly concentrated at 100 mg/ml. It also maintains stability at 25 (77°F) for 30 days to provide longer shelf life than Humira and is administered via a latex-free device.

“The launch of Yuflyma is a critical milestone not only for Celltrion USA, but for patients, healthcare providers and payers,” said Tom Nusbickel, chief commercial officer at Celltrion USA. “We are committed to providing a patient-centric approach with a focus on increased access to innovative, high-quality biologics in the United States.”

Professor Jonathan Kay of UMass Chan Medical School, said, “The launch of Yuflyma provides patients with one of only a few FDA-approved adalimumab biosimilars that has a high-concentration, citrate-free formulation. This formulation can reduce injection discomfort for patients with chronic conditions like rheumatoid arthritis, thereby improving adherence to treatment.”

Celltrion said it is seeking an interchangeability designation from the FDA for Yuflyma, tentatively expected Q4 in 2024.

Yet another biosimilar to Humira is Yusimry (adalimumab-aqvh) from Coherus.

The company said it is offering Yusimry at a list price of $995 per carton for two 40 mg/0.8 ml autoinjectors, representing a discount of more than 85% to Humira, currently priced at $6,922 per carton of two pens.

“Adalimumab products are important medicines for the treatment of serious autoimmune diseases, but cost is a barrier for many patients. With the launch of Yusimry, patients are now able to choose and access a high-quality, safe and effective treatment at significant savings compared to Humira,” said Denny Lanfear, Coherus’ chairman and CEO.

Lanfear continued, “The price of Humira is nearly $90,000 a year today, putting this important therapy out of reach for many patients who are experiencing difficult financial health challenges. Our price for Yusimary of less than $13,000 a year was enabled by our investment in robust large-scale manufacturing, allowing us to be a high-volume, low-cost adalimumab biosimilar producer, ensuring reliable supply and passing the savings directly to patients in need.”

Yusimry is presented in a state-of-the-art autoinjector and includes Coherus’ proprietary non-stinging, citrate-free formulation and a 29-gauge needle.

Biocon Biologics, a subsidiary of Biocon, is offering Hulio (adalimumab-fkjp) injection.

“The launch of Hulio, our biosimilar adalimumab, in the United States is an important milestone for Biocon Biologics as it expands our well-known biosimilar product offering to patients in the United States. This launch builds on our strong presence in oncology and diabetes and re-affirms our commitment to enabling affordable access to biologics,” said Shreehas Tambe, CEO and managing director of Biocon Biologics.

“Biocon Biologics is pleased to make Hulio, a patient-friendly, 2-click, prefilled pen available in the United States for patients with certain inflammatory diseases. There are no buttons to push. Patients remove the cap and push the device against their skin to trigger their injection. Designed and built with patients in mind, healthcare professionals and patients don’t have to miss a beat with Hulio; they simply, ‘Click, Click, Go,’” said Mathew Erick, chief commercial officer of advanced markets at Biocon Biologics.

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