aBLA Filing Intelligence & Biosimilar Opportunity

Ziihera

Zanidatamab-Hrii

Anticancer

Intravenous Infusion

Ziihera is the first and only approved bispecific antibody drug. It treats unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. This drug is given to patients who have already received the other chemotherapeutic treatment.

Approval Date

20-Nov-24

Data Exclusivity Expiry

20-Nov-28

Market Exclusivity Expiry

20-Nov-36

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

1.5463

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

106

2027

365

2028

703

2029

1051

2030

1446

2031

1826

2032

2158

Molecule profile

Details & specifications

Molecule

Zanidatamab-Hrii

Innovator

JAZZ PHARMACEUTICALS

Dosage Form

Intravenous Infusion

Strength

30 mg/vial

Therapeutic Category

Anticancer

Usage

To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer

Good to know

Frequently asked questions

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Intelligence you can file on

Verified regulatory data

Milestones tracked against primary FDA sources and refreshed continuously.

Analyst-built projections

Seven-year sales outlooks modeled by our pharma intelligence team.

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Exclusivity windows framed around the decisions generics teams actually make.

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