aBLA Filing Intelligence & Biosimilar Opportunity

Saphnelo

Anifrolumab-Fnia

Immunomodulators

Injection Injectable

Approval Date

30-Jul-21

Data Exclusivity Expiry

30-Jul-25

Market Exclusivity Expiry

30-Jul-33

Commercial snapshot

Market performance & projections

Revenue ($M)

686

CAGR (%)

0.159

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

867

2027

1014

2028

1141

2029

1238

2030

1323

2031

1418

2032

1499

Molecule profile

Details & specifications

Molecule

Anifrolumab-Fnia

Innovator

ASTRAZENECA PHARMACEUTICALS LP

Dosage Form

Injection Injectable

Strength

300 mg/2 mL (150 mg/mL)

Therapeutic Category

Immunomodulators

Usage

To treat moderate-to severe systemic lupus erythematousus along with standard therapy

Good to know

Frequently asked questions

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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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