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Amgen Pulls European Application for Its Biosimilar Infliximab ABP 710


Amgen says it is withdrawing its European application for ABP 710, its biosimilar infliximab (referencing Remicade).

Amgen has informed the European Medicines Agency (EMA) it is withdrawing its application for ABP 710, its biosimilar infliximab (referencing Remicade).

According to the letter sent to the EMA, Amgen said the decision was due to a change in product strategy. In December, Amgen submitted a biologics license application (BLA) to the FDA for ABP 710.

In an email to The Center for Biosimilars®, a spokeswoman for Amgen elaborated by saying, “As a matter of course, Amgen constantly re-evaluates its product portfolio and focuses resources on where we can provide the most value for patients and for healthcare systems. Amgen has made the decision to withdraw the ABP 710 (biosimilar infliximab) Marketing Authorization Application with EMA and Swissmedic following a change in European product strategy. We are fully committed to the success of our broad portfolio of biosimilars—3 approved so far by the EMA and the FDA—which provide important biological treatment options.”

Remicade, sold by Johnson & Johnson, is approved in the United States for rheumatoid arthritis, plaque psoriasis, Crohn disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.

At the start of this year, Celltrion said its biosimilar infliximab, CT-P13, which is sold in Europe as Remsima, had captured 56% of the infliximab market in Europe. Resima is marketed in the United States as Inflectra. The other biosimilar infliximab sold in the United States is Renflexis, sold by Merck and manufactured by Samsung Bioepis.

Amgen’s other biosimilars under development are ABP 798, a biosimilar rituximab, and ABP 959, a biosimilar eculizumab.

Last month, the FDA approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

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