aBLA Filing Intelligence & Biosimilar Opportunity

Imaavy

Nipocalimab-Aahu

Immunomodulators

Injection

Imaavy is an IV antibody for adults and teens aged 12 and older with generalized myasthenia gravis who test positive for AChR or MuSK antibodies. It targets and blocks the FcRn receptor to reduce harmful autoantibodies and improve muscle strength.

Approval Date

29-Apr-25

Data Exclusivity Expiry

29-Apr-29

Market Exclusivity Expiry

29-Apr-37

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

210

2027

600

2028

947

2029

1,340

2030

1,595

2031

1,823

2032

2,022

Molecule profile

Details & specifications

Molecule

Nipocalimab-Aahu

Innovator

JANSSEN BIOTECH, INC.

Dosage Form

Injection

Strength

300 mg/1.62 mL and 1200 mg/6.5 mL

Therapeutic Category

Immunomodulators

Usage

To treat generalized myasthenia gravis

Good to know

Frequently asked questions

Ready to act on this opportunity?

Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.

Why Spring Bio Solution

Supported 1000+ clinical trials globally

Provides services across regulatory, legal & clinical research

Unmatched intelligence on batches, expiry, spacing, and historical data from innovators

Integrated CRO services as part of our offerings

Insights on global pricing for smarter clinical trial supply decisions

Global sourcing capability across US, EU, South Africa, Canada, Japan, Australia, New Zealand, Southeast Asia, and other key markets