Confirmed bioequivalence advances a complex haematology asset toward a global dossier and Day-1 launches across the US, EU and Rest of World.
Zug, Switzerland, 7 Aug 2026: Adalvo today announced the successful completion of the bioequivalence study for its generic avatrombopag, confirming the programme is on track for US ANDA filing. Developed as a global dossier programme spanning the US, EU and Rest of World, it is designed to position Adalvo and its commercial partners for Day-1 launches in major markets worldwide, upon expiry of applicable exclusivities and IP rights.
Developed based on the reference brand Doptelet®, avatrombopag is a second-generation thrombopoietin (TPO) receptor agonist indicated for adults with primary chronic immune thrombocytopenia (ITP), and for thrombocytopenia in adults with chronic liver disease (CLD) who are scheduled to undergo a medical procedure.
Net sales of the reference brand Doptelet, as reported by Sobi, reached SEK 5,265 million (approximately USD 555 million) in full-year 2025 and SEK 3,061 million (approximately USD 323 million) in the first half of 2026.¹
"Confirming bioequivalence for avatrombopag is an important milestone and a strong example of Adalvo's growing capability in complex haematology. Reaching this stage on an asset of this commercial and clinical importance takes deep technical expertise and disciplined regulatory execution. I am proud of the team, and proud that Adalvo continues to expand access to the specialty medicines patients need."
These developments reflect Adalvo's commitment to advancing high-quality, differentiated generic medicines and expanding future treatment options for patients through rigorous development and regulatory execution.
Doptelet® is a registered trademark of AkaRx, Inc., a Sobi company.
- Source: Sobi financial reporting, H1 2026. converted at the 5 Aug 2026 rate of SEK 9.48/USD