July 17, 2023
July 2023 has seen a flurry of biosimilars being launched in the US, with various formulations and pricing options. Below, we break down the new Humira biosimilars launching this month. Each of these biosimilars has been approved by the US Food and Drug Administration (FDA) based on thorough reviews of data showing their effectiveness and safety as compared to the original medication, Humira.
Biosimilars can have an additional FDA approval as interchangeable biosimilars. This designation means that pharmacists can substitute it for the original drug without consulting the doctor, depending on state laws. As noted, only one of the biosimilars below is interchangeable (Cyltezo).
Cyltezo: The FDA has approved Cyltezo (adalimumab-adbm) as the first interchangeable version of the popular drug Humira. Developed by Boehringer Ingelheim, Cyltezo is currently available as a 40 mg/0.8 mL, 20 mg/0.4 mL, and 10 mg/0.2 mL prefilled syringe and as a 40 mg/0.8 mL prefilled autoinjector called the Cyltezo Pen. As with all medications, the cost of Cyltezo can vary depending on insurance plan, location, and pharmacy.
Hadlima: Hadlima (adalimumab-bwwd) is developed by Samsung Bioepis and commercialized by Organon. The new formula is citrate-free, which reduces the pain experienced during injection, making it more patient-friendly. The US launch of Hadlima took place July 1, 2023. Hadlima has a sale price of $1,038 for a carton containing two pre-filled pens or syringes. According to the companies, this is an 85% discount compared to Humira’s list price.
Yuflyma: Yuflyma (adalimumab-aaty) comes in a high-concentration (100mg/mL) and citrate-free formulation. It offers patients the choice of using pre-filled syringes or autoinjectors for administering the medication. Yuflyma is available to patients in the United States as of July 1, 2023. Celltrion, the manufacturer of this biologic, is seeking an interchangeability designation from the FDA. Celltrion expects to receive this designation in the fourth quarter of 2024.
Hulio: Biocon Biologics has introduced a new injection called Hulio (adalimumab-fkjp). Hulio is offered at two pricing options: 5% below the current Humira price and 85% below the Humira price, which is currently around $6,922 for a four-week supply. Hulio is similar to Humira as it is citrate-free and made without natural rubber latex to reduce allergic reactions and comes in a prefilled pen.
Idacio: Idacio (adalimumab-aacf) is produced by Fresenius Kabi. It will be available in two forms: a prefilled syringe and a pre-filled autoinjector. Idacio has already been approved and used in many other countries. It is expected to debut with a 5% discount to Humira’s list price.
Yusimry: Yusimry (adalimumabl-aqvh), launched by Coherus BioSciences, Inc. is now available in the United States at a list price of $995 per carton for two 40mg/0.8 mL autoinjectors. Yusimry is also a citrate-free formula featuring an autoinjector with a 29-gauge needle.
Hyrimoz: Sandoz has introduced a new medication called Hyrimoz (adalimumab-adaz) in the United States. Hyrimoz is also available in a special form that contains a higher concentration of the medication and does not contain citrate. This unique formulation allows for a 50% reduction in the volume of the injection, which means that certain patients may need to take fewer injections. Sandoz believes that this development could be beneficial for some individuals.