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Humira will soon have a citrate-free biosimilar available on the market.
  • Humira (adalimumab) is a popular medication used to treat various inflammatory conditions including arthritis, ulcerative colitis, and plaque psoriasis.
  • Biosimilars of such biological treatments act similarly to the name brand but can provide competition in the pharmacology market.
  • Samsung Bioepis and Organon recently announced that the FDA has approved their citrate-free high-concentration biosimilar to Humira called Hadlima (adalimumab-bwwd).
  • Once Hadlima is available to consumers, it will provide another treatment option for people with arthritis and several other conditions, possibly driving down market costs for these types of medications.

There are several chronic conditions that can be difficult to treat. Rheumatoid arthritis, ulcerative colitis, and psoriasis are some examples, which involve chronic inflammation related to immune system disorders.

Experts and pharmaceutical companies work to develop medications that can treat and manage these disorders. When new medications are developed, they must undergo testing and approval processes.

Hadlima (adalimumab-bwwd), developed by South Korea-based biotech firm Samsung Bioepis and to be commercialized by global healthcare company Organon, became the latest medication to gain the approval of the Food and Drug Administration (FDA) for the treatment of several disorders, including arthritis, ulcerative colitis, and plaque psoriasis.

Conditions where the body’s immune system reacts abnormally can be challenging to manage. Many of these conditions are chronic and require long-term management:

  • rheumatoid arthritis (RA), where the immune system attacks cells, contributing to joint pain and inflammation
  • ulcerative colitis, where the immune system causes inflammation and ulcers to form in a person’s large intestine
  • psoriasis, where the immune system attacks the body and causes skin problems and can even affect the joints in psoriatic arthritis

Humira is one medication that can help treat these conditions. It contains the active drug adalimumab, and is administered as an injection. It is classed as a biologic medication, and more specifically, a tumor necrosis factor (TNF) blocker. TNF is a protein made by the body that causes and controls inflammation.

Since Humira is a specific brand, companies can look into creating biosimilars of the product.

The FDA defines a biosimilar as “a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.”

The FDA’s approval was specifically for a citrate-free high-concentration version of HADLIMA (adalimumab-bwwd). The FDA had already approved a low-concentration version of the medication.

This new version of the medication will help provide an alternative for people eligible for Humira, opening it up as a treatment option for several disorders, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease.

Rheumatologist Dr. Joseph R. Martinez was excited about the approval of this new medication and shared his thoughts with Medical News Today:

“The FDA approval of Hadlima adds to the growing list of treatment options accessible to patients with certain autoimmune conditions. [P]atients can discuss this treatment option with their rheumatologist and decide if this is a good choice for them.”

The citrate-free component of this medication is one of the critical factors, ideally making this feature more available to consumers.

“The citrate-free formulation reduces the pain following the injection, making this a more patient-friendly treatment.”
— Dr. Joseph R. Martinez

Nancy Mitchell, registered nurse and contributing writer at Assisted Living, also underscored the significance of the citrate-free component of the medication. She explained to MNT:

“The citrate-free version of Humira has been effective in treating inflammatory symptoms of arthritis types, without the side effects of the initial drug. Originally, senior patients taking Humira complained of experiencing discomfort, possibly due to the citrate buffer in the serum. The citrate worked to maintain optimum pH levels and, in turn, preserve the shelf life and viability of the drug. Some studies have shown a slight correlation between citrates in synovial fluid and inflammation in the joints.”

“With this drug (Hadlima) being FDA-approved now, there’s hope that more patients will have access to this enhanced medication.”
— Nancy Mitchell, registered nurse

The FDA approval of Hadlima is another step in getting this medication available to the public. However, there are still several steps that the company and medical professionals will need to take.

Joe Azzinaro, vice president and global commercial lead for biosimilars at Organon, elaborated to MNT:

“Following approval, we’ll begin preparing to launch Hadlima, which will take place on or after July 1, 2023, in the U.S. in accordance with a licensing agreement with AbbVie Inc., the maker of Humira (adalimumab).”

Even after this medication becomes available, people will need to work closely with their doctors and other medical professionals to ensure it is a good fit for them. Just like Humira has specific side effects and risks, Hadlima does as well.

For example, people taking Hadlima can have an increased risk for serious infections, lymphoma and other cancers, and hypersensitivity reactions. Doctors can help guide people in choosing appropriate medications and help to monitor their use.

Nevertheless, it is exciting news for patients and healthcare providers to have an alternative to Humira, which will hopefully reduce medication costs and improve health outcomes.

“Today, adalimumab is the largest drug expense in the U.S. Given its widespread use, we’re excited to make our biosimilar available for the many people who are prescribed adalimumab to treat various chronic autoimmune conditions and, by increasing competition in the market, to potentially improve access for more patients.”
— Joe Azzinaro, vice president at Organon