Biogen Receives Positive CHMP Opinion for TOFIDENCE (tocilizumab), a Biosimilar Referencing ROACTEMRA - Seite 2

Biogen and Bio-Thera entered into a commercialization and licensing agreement for TOFIDENCE (BAT1806/BIIB800) in April 2021. Under the agreement, TOFIDENCE, developed by Bio-Thera, is to be commercialized by Biogen in the European Union. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to TOFIDENCE in all countries excluding China (including Hong Kong, Macau and Taiwan).

About TOFIDENCE (tocilizumab)
TOFIDENCE (tocilizumab), an inteleukin-6 receptor antagonist, is a treatment developed as a biosimilar to the reference product ROACTEMRA. TOFIDENCE is indicated for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.  

Indications
Rheumatoid Arthritis (RA)
Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to, or who were intolerant to, one or more Disease-Modifying Anti-Rheumatic Drug (DMARD) or tumor necrosis factor (TNF) antagonist.

Adult patients with severe, active and progressive RA not previously treated with methotrexate (MTX).

In these patients, TOFIDENCE can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have responded inadequately to previous therapy with MTX. In these patients, TOFIDENCE can be given as monotherapy in case of intolerance to MTX or where continued treatment with methotrexate (MTX) is inappropriate.

Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. TOFIDENCE can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

Coronavirus disease 2019 (Covid-19)
Adult patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.