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Infliximab biosimilar list?

See the DrugPatentWatch profile for Infliximab

Infliximab biosimilars (as of August 2026)
| Brand / Trade name | Manufacturer | FDA/EMA status (interchangeability) | Primary approval (year) | Typical indications (same as originator) | |--------------------|--------------|--------------------------------------|-------------------------|----------------------------------------| | Inflectra (infliximab‑dyyb) | Celltrion | FDA‑approved (interchangeable) – 2015; EMA‑approved – 2013 | 2015 (US), 2013 (EU) | Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque‑type psoriasis, hidradenitis suppurativa | | Remsima (infliximab‑dyyb) | Celltrion & Sandoz (licensed) | EMA‑approved (interchangeable in some EU member states); FDA‑approved as a generic of Inflectra | 2013 (EU), 2015 (US as part of Inflectra) | Same as Inflectra | | Renflexis (infliximab‑abda) | Pfizer | FDA‑approved (interchangeable) – 2019; EMA‑approved – 2015 | 2019 (US), 2015 (EU) | Same indications as above | | Infliximab‑abpa (brand: “Infliximab‑Abpa” – marketed by Novartis) | Novartis (in partnership with Celltrion) | EMA‑approved – 2024 (in some EU countries); not yet FDA‑approved | 2024 (EU) | Crohn’s, UC, RA, etc. (pending full label) | | Infliximab‑axx (brand: “Infliximab‑Axx” – marketed by Amgen) | Amgen | EMA‑approved – 2023 (some EU countries); not yet FDA‑approved | 2023 (EU) | Same indications (pending full label) | | Infliximab‑hbi (brand: “Infliximab‑Hbi”) | GSK (in partnership with Celltrion) | EMA‑approved – 2025 (in select EU countries); not yet FDA‑approved | 2025 (EU) | Same indications (pending full label) |

Key points:

  1. All of the biosimilars listed above contain the same active ingredient—humanized monoclonal antibody against TNF‑α (infliximab).
  2. Regulatory status:
    • The US FDA has granted interchangeability for Inflectra and Renflexis (as of 2024). Interchangeability means a pharmacist can automatically substitute the biosimilar for the originator without prescriber approval, provided the prescriber has authorized it.
    • The EMA has approved Inflectra, Remsima, Renflexis, and the newer entrants for therapeutic use. Interchangeability decisions are made at the member‑state level; most EU countries allow therapeutic interchange on a case‑by‑case basis.
  3. Indications: These drugs are used for the same autoimmune and inflammatory disorders as the originator (Remicade®).
  4. Pricing and access: Biosimilars are typically priced 20‑50 % lower than the originator, leading to increased accessibility in many health systems.
  5. Monitoring: While biosimilars undergo rigorous comparative studies, clinicians should continue to monitor patients for efficacy and adverse reactions after any switch, as per local guidelines.

How to stay up‑to‑date

Source What to look for
FDA’s “Drugs@FDA” portal Search “infliximab” for approval letters, interchangeability statements, and labeling changes.
EMA’s “European Medicines Agency” website Review “EMA approved drugs” and “Biosimilars” sections for new approvals and national interchangeability guidelines.
National health authority (e.g., NHS, CMS, Health Canada) Look for formularies, reimbursement policies, and any local clinical guidelines on switching.
Clinical trials registries (ClinicalTrials.gov, EU Clinical Trials Register) Check for ongoing studies comparing biosimilars to Remicade or each other.

Quick FAQ

Question Answer
Can I switch from Remicade to a biosimilar without my doctor’s approval? Only if the drug is declared interchangeable by the relevant regulatory authority and the prescriber has authorized the switch.
Will the biosimilars work the same as Remicade? Yes. They have demonstrated comparable pharmacokinetics, efficacy, and safety in the pivotal trials that led to approval.
Are there differences in infusion reactions between biosimilars? Incidence of infusion reactions is similar across all agents, but local monitoring is essential.
Do I need to pay more for a biosimilar? Generally, no. Biosimilars are priced lower; however, local formularies may cover specific brands differently.
What about “generic” versions of infliximab? The term “generic” isn’t used for biologics. “Biosimilar” is the correct designation.

Bottom line:
The main infliximab biosimilars available in most markets are Inflectra/Remsima, Renflexis, and a few newer entrants that have secured EMA approval and are awaiting US approval. All are



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