aBLA Filing Intelligence & Biosimilar Opportunity

Rystiggo

Rozanolixizumab-Noli

Immunomodulators

Subcutaneous Injection

Rystiggo is a weekly subcutaneous infusion for adults with generalized myasthenia gravis. It lowers harmful antibodies that disrupt communication between nerves and muscles.

Approval Date

26-Jun-23

Data Exclusivity Expiry

26-Jun-27

Market Exclusivity Expiry

26-Jun-35

Commercial snapshot

Market performance & projections

Revenue ($M)

375

CAGR (%)

43.50%

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

932

2027

1,169

2028

1,398

2029

1,590

2030

1,744

2031

1,912

2032

2,068

Molecule profile

Details & specifications

Molecule

Rozanolixizumab-Noli

Innovator

UCB

Dosage Form

Subcutaneous Injection

Strength

280 mg/2 mL

Therapeutic Category

Immunomodulators

Usage

To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive

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