Infliximab and Adalimumab are the only two IBD biologic therapies that have FDA approved biosimilars on the market in the United States. There are additional biosimilars in development that will likely become available in the next few years.
Infliximab Biosimilar
Infliximab, brand name Remicade®, currently has three biosimilars on the market in the United States: Inflectra®, Renflexis®, and Avsola®. Ixifi® is an Infliximab biosimilar that received FDA approval in the United States but is not yet available on the market. There are additional Infliximab biosimilars in the pipeline (e.g., GP2018 & NI-071).
Adalimumab Biosimilars
Adalimumab, brand name Humira®, has nine biosimilars that are FDA approved. The table below shows each available biosimilar by product name, company, and dosage forms that are available. The table also lists the differences based on concentration, FDA approval for interchangeability, and citrate free.
Humira Exclusivity
The timing in which biosimilar medications hit the market is based on patent expirations. Following FDA approval for a particular indication on the originator medication, there are seven years of orphan exclusivity followed by an additional 6 months of exclusivity for any pediatric indication before the biosimilars can hit the market. For example, the originator biologic, Humira, was initially approved for pediatric Crohn’s disease in September 2014, and thus its exclusivity protection did not end until March 2022. However, the indication for Humira in pediatric ulcerative colitis was not approved until Feb 2021. Because of the this, biosimilars will not be approved for pediatric ulcerative colitis until the exclusivity ends in August 2028.
Available Adalimumab Biosimilars
| Drug (-suffix) | Manufacturer | Dosage Forms Available | High or Low Concentration | Citrate free | Interchangeability |
| Abrilada (-afzb) | Pfizer | AUTOINJECTOR PEN: 40 mg/0.8 mL SYRINGE: 40 mg/0.8 mL 20 mg/0.4 mL 10 mg/0.2 mL | High | Yes | Yes |
| Amjevita (-atto) | Amgen | AUTOINJECTOR PEN: 80 mcg/0.8 mL 40 mg/0.8 mL 40 mcg/0.4 mL SYRINGE: 80 mg/0.8 mL 40 mg/0.4 mL 20 mg/0.2 mL | High and Low | Yes | No, but trial on going |
| Cyltezo (-adbm) | Boehringer Ingelheim | AUTOINJECTOR PEN: 40 mg/0.8 mL SYRINGE: 40 mg/0.8 mL 20 mg/0.4 mL 10 mg/0.2 mL | Low | Yes | Yes |
| Hadlima (-bwwd) | Organon | AUTOINJECTOR PEN: 40 mg/0.8 mL 40 mg/0.4 mL SYRINGE: 40 mg/0.8 mL 40 mg/0.4 mL | Low and High | Low concentration is not citrate free High concentration is citrate free | No |
| Hulio (-fkjp) | Myaln (Viatris) | AUTOINJECTOR PEN: 40 mg/0.8 mL SYRINGE: 40 mg/0.8 mL 20 mg/0.4 mL | Low | Yes | No |
| Hyrimoz (-adaz) | Sandoz | AUTOINJECTOR PEN: 80 mg/0.8 mL 40 mg/0.4 mL 80 mg/0.8 mL SYRINGE: 10 mg/0.1 mL 20 mg/0.2 mL 40 mg/0.4 mL 80 mg/0.8 mL | High and Low | Low concentration is not citrate free High concentration is citrate free | No |
| Idacio (-aacf) | Fresenius Kabi | AUTOINJECTOR PEN: 40 mg/0.8 mL SYRINGE: 40 mg/0.8 mL | Low | Yes | No |
| Yuflyma (-aaty) | Celltrion | AUTOINJECTOR PEN: 40 mg/0.4 mL SYRINGE: 40 mg/0.4 mL | High | Yes | No, but pursuing interchangeability |
| Yusimry (-aqvh) | Coherus | AUTOINJECTOR PEN: 40 mg/0.8 mL | Low | Yes | No |
| Simlandi (-ryvk) | Alvotech and Teva | Coming Soon | High | Yes | Yes |
Adalimumab Biosimilar Financial Support
| Drug (-suffix) | Copay Assistance (cost, annual max, how to enroll) | Patient Assistance Program Details (underinsured vs un-insured) |
| Abrilada (-afzb) | $0/month Maximum $15,000/year HCP Portal (pfizerencompassonline.com) via phone at 1-844-722-6672 | Pfizer RxPathway Uninsured: Yes Underinsured: Commercially insured not eligible |
| Amjevita (-atto) | $0/month Maximum varies depending on insurance plan Financial Support | Amjevita via phone at 1-888-826-5384 | Amgen Safety Net Foundation Uninsured: Yes Underinsured: No |
| Cyltezo (-adbm) | $0/month Does not mention an annual maximum Financial Support | Cyltezo via phone at 1-833-295-8396 | BI Cares Foundation Uninsured: Yes Underinsured: No |
| Hadlima (-bwwd) | $0/month Does not mention an annual maximum Financial Support | Hadlima via phone at 1-833-4HADLIMA (1-833-442-3546) | Harmony by Organon Patient Assistance Program Uninsured: Yes Underinsured: No |
| Hulio (-fkjp) | $0/month Maximum varies depending on insurance plan Financial Support | Hulio via phone at 1-833-444-4856 | Viatris Patient Assistance Program Uninsured: Yes Underinsured: Only those insured without prescription drug insurance |
| Hyrimoz (-adaz) | $0/month Does not mention an annual maximum Financial Support | Hyrimoz via phone at 1-833-497-4669 | Sandoz Patient Assistance Program Uninsured: Yes Underinsured: Yes $200 debit card eligible if switching |
| Idacio (-aacf) | $0/month Maximum varies depending on insurance plan Financial Support | Idacio via phone at 1-833-522-4227 | KabiCare Patient Support Program Uninsured: Yes Underinsured: Yes |
| Yuflyma (-aaty) | $0/month Maximum amount is unknown Financial Support | Yuflyma via phone at 1-877-812-6662 | Celltrion CONNECT Patient Assistance Program Uninsured: Yes Underinsured: Yes |
| Yusimry (-aqvh) | None available | None available |
| Simlandi (-ryvk) | Alvotech and Teva | Write coming soon |
Adalimumab National Drug Code and Price
| Drug (-suffix) | Manufacturer | Dosage Forms Available Package: (NDC) – Price (based on Jan 2024) *marked if unbranded* |
| Abrilada (-afzb) | Pfizer | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×1: (00069-0325-01) – $3,043.28 o 1×2: (00069-0325-02) – $6,086.54 SyRINGE: 40 mg/0.8 mL o 1×2: (00069-0328-02) – $6,086.54 20 mg/0.4 mL o 1×2: (00069-0333-02) – $6,086.54 |
| Amjevita (-atto) | Amgen | AUTOINJECTOR PEN: 80 mg/0.8 mL o 1×1: (55513-0481-01) – $1,282.02 o 1×2: (55513-0481-02) – $2,564.04 40 mg/0.8 mL o 1×1: (72511-0400-01) – $1,441.55 o 1×1: (55513-0400-01) – $3,043.27 o 1×2: (72511-0400-02) – $2,883.10 40 mcg/0.4 m L o 1×1: (55513-0482-01) – $641.01 o 1×2: (55513-0482-02) – $1,282.02 SYRINGE: 40 mg/0.8 mL o 1×1: (55513-0410-01) – $3,043.97 40 mg/0.4 mL o 1×1: (55513-0479-01) – $641.01 o 1×2: (55513-0479-02) – $1,282.02 20 mg/0.4 mL o 1×1: (55513-0411-01) – $3,043.27 20 mcg/0.2 mL o 1×1: (55513-0399-01) – $641.01 10 mg/0.2 mL o 1×1: (55513-0413-01) – $3,043.27 |
| Cyltezo (-adbm) | Boehringer Ingelheim | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×2: (00597-0375-97) – $6,086.54 o 1×2: (00597-0545-22) – $1,217.31 *unbranded* o Psoriasis SP: 1×4: (00597-0375-23) – $12,173.08 o 1×4: (00597-0545-44) – $2,434.62 *unbranded* o IBD SP: 1×6: (00597-0375-16) – $18,259.62 o 1×6: (00597-0545-66) – $3,651.92 *unbranded* SYRINGE: 40 mg/0.8 mL o 1×2: (00597-0370-82) – $6,086.54 o 1×2: (00597-0595-20) – $1,217.31 *unbranded* 20 mg/0.4 mL o 1×2: (00597-0405-80) – $6,086.54 o 1×2: (00597-0555-80) – $1,217.31 *unbranded* 10 mg/0.2 mL o 1×2: (00597-0400-89) – $6,086.54 o 1×2: (00597-0585-89) – $1,217.31 *unbranded* |
| Hadlima (-bwwd) | Organon | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×2: (78206-0184-01) – $960.67 40 mg/0.4 mL o 1×2: (78206-0187-01) – $960.67 SYRINGE: 40 mg/0.8 mL o 1×2: (78206-0183-01) – $960.67 40 mg/0.4 mL 1×2: (78206-0186-01) – $960.67 |
| Hulio (-fkjp) | Myaln (Viatris) | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×2: (49502-0380-02) – $6,078.20 o 1×2: (49502-0416-02) – $920.86 *unbranded* SYRINGE: 40 mg/0.8 mL o 1×2: (49502-0382-02) – $6,078.20 o 1×2: (49502-0418-02) – $920.86 *unbranded* 20 mg/0.4 mL o 1×2: (49502-0381-02) – $6,078.20 1×2: (49502-0417-02) – $920.86 *unbranded* |
| Hyrimoz (-adaz) | Sandoz | AUTOINJECTOR PEN: 80 mg/0.8 mL and 40 mg/0.4mL o Psoriasis SP: 1x80mg, 2×40 mg: (61314-517-36) – $12,173.11 40 mg/0.4 mL o 1×2: (61314-0473-20) – $6,086.54 o 1×2: (61314-0327-20) – $1,217.31 – *unbranded* 80 mg/0.8 mL o IBD SP: 1×3: (61314-454-36) – $18,259.69 o 1×2: (61314-0454-20) – $12,173.11 SYRINGE: 10 mg/0.1 mL o 1×2: (61314-0509-64) – $6,086.54 20 mg/0.2 mL o 1×2: (61314-0476-64) – $6,086.54 40 mg/0.4 mL o 1×2: (61314-0473-64) – $6,086.54 o 1×2: (61314-0327-64) – $1,217.31 – *unbranded* 80 mg/0.8 mL o Ped IBD SP: 1×3: (61314-0454-68) – $18,259.69 80 mg/0.8 mL and 40 mg/0.4mL Ped IBD SP: 1x80mg, 1×40 mg: (61314-0531-64) – $9,129.84 |
| Idacio (-aacf) | Fresenius Kabi | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×2: (65219-0554-08) – $6,086.54 o Psoriasis SP: 1×4: (65219-0554-28) – $12,173.08 o IBD SP: 1×6: (65219-0554-38) – $18,259.62 SYRINGE: 40 mg/0.8 mL 1×2: (65219-0556-18) – $6,086.54 |
| Yuflyma (-aaty) | Celltrion | AUTOINJECTOR: 40 mg/0.4 mL: 1×1: (72606-0030-09) – $2,891.11 1×2: (72606-0030-10) – $5,782.23 |
| Yusimry (-aqvh) | Coherus | AUTOINJECTOR: 40 mg/0.8 mL 1×2: (70114-0220-02) – $920.87 |
| Simlandi (-ryvk) | Alvotech and Teva | Write coming soon |
Biologic Biosimilar Pipeline
The biologic biosimilar pipeline does not stop with Infliximab and Adalimumab. Biosimilars are being researched for other common biologic medications indicated for IBD and other diseases. Ustekinumab, Vedolizumab, Golimumab, and Certolizumab each have biosimilars in the approval pipeline as shown below. Note that the Ustekinumab biosimilar, ABP654, has filed for FDA approval.
- Ustekinumab: NEULARA; CT-P34; FYB202; DMB-3115; AVT04; SB17; BFI-751; ABP654
- Vedolizumab: PB016
- Golimumab: BAT2506; AVT05
- Certolizumab: XCIMZANE
