Biosimilar Advancements: Understanding the Latest Updates on Humira® with Cyltezo® and Abrilada™
At the time our April 2023 Newsline article Biosimilar Adoption for Humira® in 2023 was published, eight FDA biosimilars for Humira had been approved, and five more were pending approval. As of June, three additional biosimilars are in the market and three are still pending FDA approval. In October, Abrilada™ was granted FDA approval as an interchangeable biosimilar. Now, Abrilada™ along with Cyltezo® are the only two biosimilars that are interchangeable with Humira® without the intervention of the prescribing physician, depending on state pharmacy laws. The chart below
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
from Cardinal Health’s biosimilar landscape overview provides a convenient summary.
FDA Approved
| Product | Company | Estimated launch | Interchangeability Designation Approved | Citrate free | Latex free |
| Abrilada™ | Pfizer | November 2023 | Yes | Yes | Yes |
| Amjevita™ | Amgen | January 31, 2023 | No | Yes | Yes |
| Cyltezo® | Boehringer Ingelheim |
July 1, 2023 | Yes | Yes | No |
| Hadlima™ | Organon | July 1, 2023 | No | No | Yes |
| Hadlima™ | Organon | July 31, 2023 | No | Yes | |
| Hulio® | Viatris | July 31, 2023 | No | Yes | Yes |
| Hyrimoz® | Sandoz | July 1, 2023 | No | No | No |
| Hyrimoz® | Sandoz | July 1, 2023 | No | Yes | No |
| Idacio® | Fresenius Kabi | July 2023 | No | Yes | Yes |
| Yuflyma® | Celltrion | July 1, 2023 | No | Yes | Yes |
| Yusimry™ | Coherus | July 1, 2023 | No | Yes | Yes |
Pending Approval
| Product | Company | Estimated launch | Seeking interchangeability | Citrate free | Latex free |
| Amjevita™ | Amgen | 2024; Phase III trials | Yes | Yes | No |
| AVT-02 | Teva | Pending FDA approval | Yes | Yes | Yes |
| MYL-1401A | Mylan | Phase III trials |
PAAS Tips:
- Not all biosimilars are interchangeable
- When the FDA grants an interchangeable biosimilar designation, this means the biosimilar meets additional data requirements proving patients who alternate between the reference product and the biosimilar will have the same clinical result as patients who are being treated with the reference product alone
- See Biologic Drug Substitution Best Practices in the April 2023 Newsline
- Use the FDA Purple Book as a resource for biosimilars and interchangeability
- Abrilada™ is expected to be in the market at the end of November 2023
- PAAS National® will update our Biologic Injectable Medication chart when Abrilada™ available
- Some large payers are keeping Humira® on formulary for 2023, but others may not
- Watch for soft rejects alerting pharmacies to preferred biosimilars
- PBMs may allow Humira® to process, but severely underpay the claim. Try to bill the interchangeable biosimilar first, watching claim adjudication logic, and then consider Humira DAW 9, as appropriate
Analyst at PAAS National®
I began working at an independent pharmacy in high school and really enjoyed being in the health care field. I provided clinical support to improve patient care and adherence to their medications. I have played a vital role in the pharmacy industry full-time for 23 years.
I have a Bachelor of Science degree from the University of Wisconsin-River Falls and have been a Certified Pharmacy Technician since 2001. Prior to joining the PAAS team, I was a floating technician, 3rd party district chargeback specialist, and district pharmacy training coordinator. Formerly, I was also an instructor for pharmacy technician certification classes.
PAAS’ personal, one-on-one connection will help your pharmacy become more successful in dealing with tiresome PBM audits. It is a pleasure knowing that my colleagues and I can help member pharmacies.
I have a Bachelor of Science degree from the University of Wisconsin-River Falls and have been a Certified Pharmacy Technician since 2001. Prior to joining the PAAS team, I was a floating technician, 3rd party district chargeback specialist, and district pharmacy training coordinator. Formerly, I was also an instructor for pharmacy technician certification classes.
PAAS’ personal, one-on-one connection will help your pharmacy become more successful in dealing with tiresome PBM audits. It is a pleasure knowing that my colleagues and I can help member pharmacies.
Latest posts by Jennifer Ottman, CPhT (see all)
- Are You Prepared for a Spravato® Audit? - May 6, 2024
- Documentation is Essential for Prescription Quantity Changes - April 26, 2024
- NDC Numbers: Not a Guarantee of FDA Approval - April 12, 2024
