- Accord announces that the CHMP has issued a positive opinion
for Imuldosa® (development code: DMB-3115), a biosimilar
to Stelara®, indicated for a range of immunology
conditions.
- The approval of Imuldosa® further enhances
Accord Healthcare's biosimilar portfolio and strengthens Accord's
Autoimmune Franchise building on existing leading brands.
- Imuldosa® will be the 5th biosimilar
for Accord in the EU, with a further 10 in various stages of
development.
LONDON, Oct. 19,
2024 /PRNewswire/ -- Accord Healthcare Limited
(Accord) a subsidiary of Intas Pharmaceuticals, announces that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion,
recommending marketing authorisation for Imuldosa®
(development code: DMB-3115), a biosimilar of Stelara®
(ustekinumab), marketed by Janssen Biotech Inc., a subsidiary of
Johnson & Johnson.
Ustekinumab is a human monoclonal antibody that targets the
cytokines interleukin-12 and interleukin-23 which may play an
important role in inflammatory and immune responses.
Mr. Paul Tredwell, Executive
Vice President of Accord Healthcare, said, "We are delighted with
the positive CHMP opinion for Imuldosa®. This further
strengthens our established autoimmune franchise, where Accord
already has several leading speciality brands. The recommendation
affirms Accord's continued strategy to expand its speciality
business with an industry-leading portfolio, this positive opinion,
combined with a further 10 biosimilars in development, reaffirms
our commitment to improve access to value-based medicines for
patients."
"We are truly excited by this partnership which, besides
strengthening our existing biosimilar portfolio, also reinforces
our long-term commitment towards bettering access to medicines for
patients globally," said Mr Binish
Chudgar, Executive Chairman and Managing Director of Intas
Pharmaceuticals Ltd.
References for media:
According to the EMA CHMP positive opinion, DMB-3115 is highly
similar to the reference product Stelara® (ustekinumab)
and has demonstrated comparable quality, safety and efficacy to
Stelara®. The MAA submission includes results from the
phase III multi-regional clinical trial in patients with plaque
psoriasis (NCT04785326). The study demonstrated a comparable
efficacy and safety profile between DMB-3115 and
Stelara®.
Stelara® is indicated for a range of immunology
indications and has recorded global sales of US$19 billion of which US$3.2 billion sales coming from Europe as per IQVIA MAT June 2024 data.
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