WESTON (dpa-AFX) - Biogen Inc. (BIIB) said that the Committee for Medicinal
Products for Human Use or CHMP of the European Medicines Agency or EMA adopted a
positive opinion for Tofidence (tocilizumab), a biosimilar monoclonal antibody
referencing Roactemra.

The intravenous formulation of Tofidence has been recommended for approval for
the treatment of moderate to severely active rheumatoid arthritis, polyarticular
juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and
COVID-19.

The CHMP's positive opinion will now be referred to the European Commission,
which will decide whether to grant marketing authorization for Tofidence.

If a marketing authorization is granted by the European Commission, Tofidence
will be an addition to the existing biosimilars portfolio of three widely
prescribed anti-TNF biosimilars commercialized by Biogen in Europe. They are
Benepali (etanercept), Imraldi (adalimumab) and Flixabi (infliximab).

Biogen and Bio-Thera reached a commercialization and licensing agreement for
Tofidence (BAT1806/BIIB800) in April 2021. As per the deal, 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).

For More Such Health News, visit rttnews.com.



Copyright(c) 2024 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX