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 Ten biosimilars that are FDA approved. Only nine on available on the market in the U.S. 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) DRUG DISCONTINUED | Pfizer | DRUG DISCONTINUED | DRUG DISCONTINUED | DRUG DISCONTINUED | DRUG DISCONTINUED |
| Amjevita (-atto) | Amgen | AUTOINJECTOR PEN: 80 mcg/0.8 mL 40 mcg/0.4 mL SYRINGE: 40 mg/0.4 mL 20 mg/0.2 mL 10 mg/0.2 mL | High and Low | Yes | No, but trial on going |
| Cyltezo (-adbm) | Boehringer Ingelheim | AUTOINJECTOR PEN: 40 mg/0.8 mL 40 mg/0.4 mL SYRINGE: 40 mg/0.8 mL 40 mg/0.4 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 40 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 80 mg/0.8 mL SYRINGE: 20 mg/0.2 mL 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 | AUTOINJECTOR PEN: 40 mg/0.4 mL 80mg/0.8 mL SYRINGE: 20 mg/0.2 mL 40 mg/0.4 mL | 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) |
| Humira | $0/month Humira CoPAY Assistance Call 1.800.4HUMIRA | |
| Abrilada (-afzb) | DISCONTINUED | DRUG DISCONTINUED |
| 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 1-833-444-8546 | Viatris Patient Assistance Program Uninsured: Yes Underinsured: Only those insured without prescription drug insurance |
| Hyrimoz (-adaz) | $0/month Adalimumab-adaz copay max = $4,250 Brand Hyrimoz copay max = $10,000 Brand Hyrimoz (Cordavis version) copay max = $5,250 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 $14,000 Financial Support | Yuflyma via phone at 1-877-812-6662 | Celltrion CONNECT Patient Assistance Program Uninsured: Yes Underinsured: Yes |
| Yusimry (-aqvh) | $0/month Max: $100 per 28 day fill or $300 per 84 day fill | None available |
| Simlandi (-ryvk) | $0/month Max $9.200 Phone 1-844-735-9935 |
Adalimumab National Drug Code and Price
| Drug (-suffix) | Manufacturer | Dosage Forms Available Package: (NDC) – Price (based on Dec 2024) *marked if unbranded* |
| Abrilada (-afzb) | Pfizer | DRUG DISCONTINUED |
| Amjevita (-atto) | Amgen | AUTOINJECTOR PEN: 80 mg/0.8 mL o 1×1: (55513-0481-01) – $1,281 o 1×2: (55513-0481-02) – $2,562 40 mcg/0.4 m L o 1×1: (55513-0482-01) – $640 o 1×2: (55513-0482-02) – $1,281 SYRINGE: 40 mg/0.4 mL o 1×1: (55513-0479-01) – $640 o 1×2: (55513-0479-02) – $1,281 20 mcg/0.2 mL o 1×1: (55513-0399-01) – $640 10 mg/0.2 mL o 1×1: (55513-0413-01) – $3,041 |
| Cyltezo (-adbm) | Boehringer Ingelheim | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×2: (00597-0375-97) – $6,083 o 1×2: (00597-0545-22) – $1,216 *unbranded* 40 mg/0.4 mL o 1×2: (00597-0495-50) – $6,083 o 1×2: (00597-0575-50) – $1,216.65 *unbranded* Psoriasis SP: o 1×4: (00597-0375-23) – $12,166 IBD SP: o 1×6: (00597-0375-16) – $18,259 SYRINGE: 40 mg/0.8 mL o 1×2: (00597-0370-82) – $6,083 o 1×2: (00597-0595-20) – $1,216 *unbranded* 40 mg/0.4 mL o 1×2: (00597-0485-20) – $6,083.25 (New item not yet available) 20 mg/0.4 mL o 1×2: (00597-0405-80) – $6,083 o 1×2: (00597-0555-80) – $1,216 *unbranded* 10 mg/0.2 mL o 1×2: (00597-0400-89) – $6,083 o 1×2: (00597-0585-89) – $1,216 *unbranded* |
| Hadlima (-bwwd) | Organon | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×2: (78206-0184-01) – $960 40 mg/0.4 mL o 1×2: (78206-0187-01) – $960 SYRINGE: 40 mg/0.8 mL o 1×2: (78206-0183-01) – $960 40 mg/0.4 mL 1×2: (78206-0186-01) – $960 |
| Hulio (-fkjp) | Myaln (Viatris) | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×2: (49502-0416-02) – $920 *unbranded* SYRINGE: 40 mg/0.8 mL o 1×2: (49502-0418-02) – $920 *unbranded* 20 mg/0.4 mL o 1×2: (49502-0381-02) – $6,083 o 1×2: (49502-0417-02) – $920 *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) – $12,166 40 mg/0.4 mL o 1×2: (61314-0327-20) – $1,216 – *unbranded* 80 mg/0.8 mL o IBD SP: 1×3: (61314-454-36) – $18,249 o 1×2: (61314-0454-20) – $12,166 SYRINGE: 10 mg/0.1 mL o 1×2: (61314-0509-64) – $6,083 20 mg/0.2 mL o 1×2: (61314-0476-64) – $6,083 40 mg/0.4 mL o 1×2: (61314-0473-64) – $9,124 o 1×2: (61314-0327-64) – $1,216- *unbranded* 80 mg/0.8 mL o Ped IBD SP: 1×3: (61314-0454-68) – $18,249 |
| Idacio (-aacf) | Fresenius Kabi | AUTOINJECTOR PEN: 40 mg/0.8 mL o 1×2: (65219-0554-08) – $6,052 o IBD SP: 1×6: (65219-0612-89) – $2,494.73 – *unbranded* o Psoriasis SP: 1×4: (65219-0612-69) – $1,663 *unbranded* SYRINGE: 40 mg/0.8 mL 1×2: (65219-0556-18) – $831 *unbranded* |
| Yuflyma (-aaty) | Celltrion | AUTOINJECTOR: 40 mg/0.4 mL: o 1×1: (72606-0030-09) – $833 o 1×2: (72606-0022-10) – $960 *unbranded* 80 mg/0.8 mL o 1×1: (72606-0023-04) – $876 o 1×1: (72606-0040-04) – $480 *unbranded* SYRINGE: 20 mg/0.2 mL o 1×2: (72606-0024-01) – $6,083 o 1×2: (72606-0041-01) – $960 *unbranded* 40 mg/0.4mL o 1×1: (72606-0030-06) – $1,666 |
| Yusimry (-aqvh) | Coherus | AUTOINJECTOR: 40 mg/0.8 mL o 1×2: (70114-0220-02) – $920 |
| Simlandi (-ryvk) | Alvotech and Teva | 40 mg/0.4 mL pen: o 1×1: (51759-0402-17) – $456 o 1×2: (51759-0402-02) – $912 80mg/0.8 mL pen: o 1×1: (51759-0274-17) – $912 |
Biologic Biosimilar Pipeline
The biologic biosimilar pipeline does not stop with Infliximab and Adalimumab. There are eight Ustekinumab biosimilars that are FDA approved and seven available in the U.S. Six are INTERCHANGEABLE.
| Drug (-suffix) | Manufacturer | Dosage Forms Available, NDC, & Price | Interchangeable? |
| Imuldosa (-srlf) | Accord BioPharma | 45 mg syringe ($1166.06) 90 mg syringe ($2332.12) 130 mg vial ($1483.76) 92% discount from Wholesale Acquisition Cost from Stelara | Not yet – anticipated early 2026 |
| Otulfi (-aauz) “Ahh-toll-fee” | Formycon and Fresenius Kabi | 45 mg syringe 90 mg syringe 130 mg single-dose vial | Yes |
| Pyzchiva (-ttwe) | Sandoz Quallant | 45 mg syringe 90 mg syringe 130 mg single-dose vial | Yes |
| Selarsdi (-aekn) | Alvotech and Teva | 45 mg syringe 90 mg syringe 130 mg single-dose vial 85% discount from Wholesale Acquisition Cost from Stelara | Yes |
| Starjemza (-hmny) | Hikma and Bio-thera Solutions | Not on the Market Yet | Not on the Market Yet |
| Steqeyma (-stba) “Sta-kay-ma” | Celltrion | 45 mg syringe 90 mg syringe 130 mg single-dose vial | Yes |
| Yesintek (-kfce) | Biocon Biologic | 45 mg syringe 90 mg syringe 130 mg single-dose vial 29G needle which is thinner than Stelara (27G) 90% discount from Wholesale Acquisition Cost from Stelara | Yes |
| Wezlana (-auub) | Amgen | 45 mg syringe 90 mg syringe 130 mg single-dose vial 45 mg/0.5 mL single dose vial | Yes |
| Drug (-suffix) | Copay Assistance (cost, annual max, how to enroll) | Patient Assistance Program Details (% poverty level, underinsured vs un-insured) |
| Imuldosa (-srlf) | Covers down to $0 Max $6000 annually | PAP available (uninsured and underinsured) |
| Otulfi (-aauz) | -$1800 max/yr, $450 max per fill for 90 mg and 130 mg doses -$1800 max/yr, $225 max per fillfor 45 mg Can enroll here: https://portal.trialcard.com/fresenius-kabi/kabicopay/ 1-833-522-4227 | |
| Pyzchiva (-ttwe) | 1-855-726-3698 https://sandoz-onesource.com/pyzchiva/ | |
| Selarsdi (-aekn) | 1-844-211-7047 https://copayportal.paysign.com/enrollment/4515430394/index.html | |
| Stelara | PAP available through J&J 300% poverty levels through 2026 | |
| Steqeyma (-stba) | Celltrion Connect $5/month 1-844-306-3550 https://www.celltrioncares.com/inquiry-form/steqeyma. | 500% poverty level Uninsured or functionally uninsured (have insurance but patient is responsible for close to 100% of medication cost, must have 2 denied appeals, insurance plan excludes |
| Yesintek (-kfce) | Copay card ($0 copay) 1-833-612-4626, https://mybioconbiologics-digitalenrollment.caremetx.com/ | Uninsured and underinsured (400-500% poverty level) |
| Wezlana (-auub) | 1-833-442-6436 https://www.wezlana.com/patient/co-pay |
Vedolizumab, Golimumab, and Certolizumab each have biosimilars in the approval pipeline as shown below.
- Vedolizumab: PB016; AVT16
- Golimumab: BAT2506; AVT05
- Certolizumab: XCIMZANE