A Watershed For Biosimliars: EU Recommends Copies Of Remicade

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In a defining moment for the advent of biosimilars, European regulators have recommended two versions of the blockbuster injectable treatment, marking the first time that such an endorsement has been issued for monoclonal antibodies.

The recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use was given to biosimilars from South Korea’s Celltrion and Hospira for the same indications granted Remicade – a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis (here is the statement).

Until now, such complex biologics as monoclonal antibodies have faced relatively little generic competition, but the CHMP recommendation signals that regulators are eager to clear a so-called pathway for a wider array of biosimilars. This occurs, by the way, as European governments increasingly grapple with rising costs for all sorts of medicines.

“This is a moment for the field of biosimilars,” Sanford Bernstein analyst Ronny Gal writes in an investor note. Monoclonal antibodies “are substantially larger and more complex than prior approved biologics.  Some argued EMA will struggle with setting the right bar for these products and developers will struggle to meet it.  Now the argument gets essentially reversed.”

In his view, a standard has now been set to apply the same regulatory approach toward all monoclonal antibodies. And since Celltrion, which he describes as a “relative unknown,” has met the EMA approval bar, this suggests more established drugmakers will pass muster going forward. It is worth noting that pivotal…Read more

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