- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
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.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
