) recently announced that its generic arm, Sandoz, has initiated
a phase III study for its biosimilar version of
) Enbrel (etanercept).
We note that Enbrel is approved for several indications
including the treatment of moderate to severe active rheumatoid
arthritis and psoriasis.
The main aim of the phase III study is to establish
biosimilarity on safety, efficacy and immunogenicity compared to
Enbrel for the treatment of patients with moderate to severe
chronic plaque-type psoriasis. Positive results from this study
will support regulatory filings in the US and EU.
Amgen has a collaboration agreement with
) whereby the marketing rights for Enbrel outside the US and
Canada is reserved with the latter.
We note that Enbrel was a key revenue generator for Amgen in
2012 with sales of $4.2 billion, up 14.4%.
Meanwhile, Sandoz is also developing biosimilar versions of
Amgen's Neulasta (pegfilgrastim) and Neupogen (filgrastim).
Both drugs are approved for stimulating white blood cell
production in the body.
According to IMS Health, Sandoz is a leader in the global
biosimilars market. The company has three marketed products which
account for about 50% of all biosimilars in the combined regions
of North America, Europe, Japan and Australia.
Sandoz currently has seven phase III studies across five
biosimilar molecules in its arena. We are encouraged by Sandoz's
efforts to broaden its portfolio which should boost sales in the
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #2 (Buy).
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