OnCo
drugsProductApproved2017🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

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.

Loading structure…
|
Trastuzumab Fab bound to HER2 extracellular domain (PDB 1N8Z), backbone trace
RCSB PDB
Modality
Biosimilar monoclonal antibody (anti-HER2)
Mechanism
Same amino acid sequence and mechanism as trastuzumab; analytical and clinical equivalence demonstrated.
Brand / code
Ogivri, Herzuma, Kanjinti, Trazimera, Ontruzant, Hercessi
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.

Not appraisedSearch NICE
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.

Regulatory

2top

Approvals

RegionYearIndication
US2017First trastuzumab biosimilar (Ogivri); all trastuzumab indications
EU2017Ontruzant, first EU trastuzumab biosimilar

Trials

top

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Trastuzumab biosimilars
intervention: Trastuzumab biosimilars
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Latest papers

top
Literature trend7 papers in the last 12 months0% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query 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.

Connected

8top