The shift from biologic to biosimilar
Remicade is the brand name for the reference biologic, infliximab, which is a monoclonal antibody. Unlike small-molecule drugs, biologics are made from living cells and have complex structures that cannot be exactly replicated to create generic versions.
When a reference biologic's patent expires, other companies can develop biosimilars. The FDA defines a biosimilar as a biological product highly similar to the reference product with no clinically meaningful differences in safety, purity, and potency. This ensures that biosimilars provide comparable therapeutic effects to the original biologic, though they are not identical copies.
Meet the infliximab biosimilars
With the expiration of Remicade's patent, several biosimilars have received FDA approval in the U.S., offering more affordable treatment options. Key FDA-approved infliximab biosimilars available in the U.S. include:
- Inflectra (infliximab-dyyb): Approved in 2016 and marketed by Pfizer.
- Renflexis (infliximab-abda): Approved in 2017.
- Avsola (infliximab-axxq): Approved in 2019 and manufactured by Amgen.
These biosimilars, like Remicade, are administered as intravenous (IV) infusions in a clinical setting.
Zymfentra: a novel subcutaneous alternative
In addition to the IV biosimilars, a subcutaneous (SC) formulation of infliximab is available for specific uses. Zymfentra (infliximab-dyyb), developed by Celltrion, received FDA approval in 2023. Zymfentra allows for self-administration as an under-the-skin injection, providing convenience for some patients.
Zymfentra is not classified as a biosimilar to Remicade due to its different administration method. It is approved for the maintenance treatment of moderately to severely active Crohn's disease and ulcerative colitis in adults after completing an intravenous induction with an infliximab product.
Remicade vs. its alternatives: a comparison
The table below highlights key differences:
| Feature | Remicade | Inflectra / Renflexis / Avsola | Zymfentra |
|---|---|---|---|
| Active Ingredient | Infliximab | Infliximab-dyyb, infliximab-abda, etc. | Infliximab-dyyb |
| Product Type | Reference Biologic | Biosimilars | Novel Biologic |
| Route of Administration | Intravenous (IV) Infusion | Intravenous (IV) Infusion | Subcutaneous (SC) Injection |
| Administration Location | Clinic or infusion center | Clinic or infusion center | At home (self-administered) |
| Indicated Use | Multiple autoimmune conditions | Same indications as Remicade | Maintenance therapy for UC/CD |
| Typical Cost | Often more expensive | Generally less expensive | Varies; potential cost savings |
Making the switch: what to consider
Switching from Remicade to a biosimilar or alternative should be discussed with a healthcare provider. Insurance companies often encourage or require a switch to lower-cost biosimilars. Studies show switching is generally safe and effective. Zymfentra offers a subcutaneous option for maintenance therapy. Your doctor can help determine the best option.
Conclusion
There is no single new name for Remicade. The market includes FDA-approved biosimilars like Inflectra, Renflexis, and Avsola (IV infusion), and Zymfentra (subcutaneous option) for maintenance therapy. These options aim to improve access and potentially reduce costs.
