EU backs Remicade biosimilars; anti-TNFs at risk

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A Friday decision by the European Medicines Agency's Committee for Medicinal Products for Human Use recommended two Remicade (infliximab) biosimilars, Remsima and Inflectra for approval. This promises to put even more pressure on existing RA therapies than did last week's reveal that Sandoz was working on a look-alike version of Amgen's Enbrel. Friday's news would benefit Celltrion, which put up Remsima for approval, and Hospira, which offered up Inflectra.

It's the first time the CHMP has recommended marketing authorizations for monoclonal-antibody biosimilars. Also of note: the agency's nod goes beyond rheumatoid arthritis and endorses the look-alike drugs for a slate of conditions, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Goldman Sachs analyst Jami Rubin wrote in a Friday research note that the wide indication approval was “somewhat surprising since Inflectra had clinical data showing similarity to Remicade in RA only.” She predicts that Inflecta could hit $284 million in sales by 2016.

The CHMP opinions on Remsima and Inflectra will now be sent to the European Commission for adoption of a final decision on marketing authorization, the EMA said. Approving both would bring the total number of approved biosimilars to 14 since 2006.

Rubin noted that CHMP's move may affect drug makers differently. For example, the analyst noted that CHMP's move to "bridge from RA to other indications" could benefit Amgen, which has biosimilars in the works for Avastin, Herceptin, Rituxan and Erbitux, and she expects Amgen's first biosimilar to launch in 2017.

The relatively immediate impact could hit Pfizer which markets Enbrel in Europe (Amgen markets the drug in the US). Rubin noted that the impact on Merck would not be material, because most of Remicade's European patent protections will lapse in February 2015. Her group had already forecast that EU sales would fall 20% in 2015 and then 30% annually, before possibly flat-lining at $600 million in annual European sales by 2018.

Rubin wrote that AbbVie's Humira may not have a weak spot in this scenario. Rubin points to Germany as the reason for AbbVie's unique position, calling the country a bellweather of sorts for the EU, and says experts have told her Germany's pricing rules would not start to hit AbbVie until a biosimilar grabs 20% of the market, and even then, the reference pricing would only affect Remicade pricing, and not fellow anti-TNFs based on Germany's rules.

Rubin said the European impact doesn't necessarily translate to US possibilities, because the FDA's draft guidance hasn't signed off on a one-application, multi-indication pathway.

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