) were positively impacted by the European Commission's decision
to approve the company's Inflectra (infliximab) for the treatment
of inflammatory conditions such as rheumatoid arthritis,
ankylosing spondylitis, Crohn's disease, ulcerative colitis,
psoriatic arthritis and psoriasis.
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We note that Inflectra is the biosimilar version of
Johnson & Johnson
Merck & Co. Inc.
) blockbuster drug Remicade. Hospira stated in its press release
that Inflectra is the first monoclonal antibody therapy to be
cleared in Europe through the European Medicines Agency (EMA)
biosimilars regulatory process. Hospira stated further that
Remicade sales had crossed the $2 billion mark in 2012.
The decision of the EC does not surprise us since in Jun 2013 the
EMA's Committee for Medicinal Products for Human Use (CHMP) had
recommended the approval of Inflectra for the treatment of
Positive results on Inflectra from a phase III study prompted the
EC to clear the drug. Inflectra met its primary endpoint of
therapeutic equivalence to Remicade in the study. Data also
revealed that the safety and tolerability of Inflectra was
comparable to Remicade. Hospira currently enjoys the rights to
Inflectra in Europe, some nations belonging to the Commonwealth
of Independent States, the U.S., Canada, Australia and New
Zealand under the agreement it signed with South Korean company,
Celltrion, in 2009.
Hospira also said in its press release that the ushering in of
monoclonal antibodies is expected to generate savings of up to
€20.4 billion in Europe by 2020. Countries like the UK, France
and Germany are expected to be the biggest beneficiaries from the
We note that Hospira boasts of a strong biosimilars pipeline.
Biosimilars, which are generic versions of biologic drugs, are
expected to be a significant growth driver in the generics
industry in the coming years. The biosimilars market represents
huge commercial opportunity with a significant amount of biologic
sales slated to lose patent protection in the coming years.
Hospira carries a Zacks Rank #3 (Hold).
) appears to be well placed in the medical sector with a Zacks
Rank #1 (Strong Buy).