Trastuzumab biosimilars
Near-identical copies of Herceptin, approved since 2017, that cut the price of HER2 treatment and widened access worldwide.
Six US-approved biosimilars (first: Ogivri, December 2017) with equivalence shown on pCR or ORR endpoints; WHO prequalification (2019) enabled low- and middle-income access. Biosimilar uptake exceeds 80% of trastuzumab volume in the US and EU; they are the trastuzumab component of many chemotherapy-antibody regimens and control arms.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Biosimilars are paid at their own average sales price plus 8% of the reference product's price under Medicare Part B, an incentive to prescribe them; patient coinsurance is generally lower than for Herceptin.
- Commercial insurance
- covered on label
Preferred products on most commercial medical-benefit formularies; plans pick one or two preferred biosimilars and may require a switch.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · FDA: Biosimilars. Not medical or financial advice; verify with your plan.
- Notes
- Biosimilars are not appraised separately: they fall under the originator's TAs (TA34, TA107, TA208). NHS England's biosimilar commissioning framework drove rapid switching from 2018.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: trastuzumab biosimilars. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2017 | First trastuzumab biosimilar (Ogivri); all trastuzumab indications |
| EU | 2017 | Ontruzant, first EU trastuzumab biosimilar |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Trastuzumab biosimilars" OR ABSTRACT:"Trastuzumab biosimilars" OR TITLE:"Ogivri" OR ABSTRACT:"Ogivri" OR TITLE:"Herzuma" OR ABSTRACT:"Herzuma" OR TITLE:"Kanjinti" OR ABSTRACT:"Kanjinti" OR TITLE:"Trazimera" OR ABSTRACT:"Trazimera" OR TITLE:"Ontruzant" OR ABSTRACT:"Ontruzant") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trastuzumab biosimilars, not a curated reading list.