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Amgen, Inc. AMGN announced positive top-line results from a late-stage study evaluating the safety and efficacy of ABP 710, its biosimilar version of J&J JNJ/Merck’s MRK Remicade, compared to the reference product for the treatment of moderate-to-severe rheumatoid arthritis (RA). ABP 710 is an anti-TNF monoclonal antibody.
Data from the phase III study showed that ABP 710 was non-inferior compared to Remicade based on its primary endpoint, which was assessment of ACR20 at week 22. The ACR (American College of Rheumatology) criteria are used to measure the effectiveness of various arthritis medicines in clinical studies. An ACR20 score means that a person's RA has improved by 20%.
The data showed that there was no clinically meaningful difference between ABP 710 and Remicade.
Amgen’s shares have gained 5.5% so far this year against a 7.6% decrease registered by the industry.
Amgen has 10 biosimilar products in its portfolio. Out of them, Amgen’s biosimilar version of Abbvie’s ABBV RA drug Humira, Amjevita, was approved by the FDA in September 2016 and in the EU in March 2017 for the same indications as Humira. Amjevita is the first biosimilar version of Humira to be approved by the FDA as well as Amgen’s first biosimilar medicine to be approved. Amgen will begin selling Amjevita in most countries in the EU this year and in the United States from January 2023.
Amgen has collaborated with Allergan for the worldwide development and commercialization of four oncology antibody biosimilar medicines. Among them, a biosimilar version of Roche’s Avastin— Mvasi — is already approved in United States and EU while a biosimilar version of Herceptin, Kanjinti, is under review in the United States and EU. A biosimilar version of Rituxan — ABP 798 — is in late-stage development.
Several of Amgen’s own drugs are facing biosimilar competition. Biosimilars are already having a negative impact on key products like Neupogen and Neulasta in the EU. In the United States, while Neupogen is already facing biosimilar competition, other key drugs like Neulasta and Epogen could start facing biosimilar competition this year. The entry of additional biosimilars in the United States will have a negative impact on the company’s top line. Sensipar also lost patent exclusivity in March 2018 and generics could be launched soon.
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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