Amgen Inc AMGN and partner Allergan’s AGN comparative clinical study evaluating ABP 798, their biosimilar candidate, to Roche’s RHHBY Rituxan showed clinical equivalence of the biosimilar product to the branded version. The study evaluated efficacy and safety of ABP 798 compared to Rituxan in patients with non-Hodgkin's lymphoma (NHL).
Top-line data from the JASMINE study showed that the primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the pre-specified margin for ABP 798 compared to Rituxan. This is the second study on ABP 798 that has shown positive top-line results.
In January, Amgen and Allergan announced positive top-line results from phase I/III study of ABP 798, evaluating pharmacokinetics, efficacy and safety of ABP 798 compared to Rituxan in patients with moderate-to-severe rheumatoid arthritis. The study met its primary endpoint of pharmacokinetic (PK) similarity. The study also established equivalent efficacy and demonstrated a similar safety profile to Rituxan.
Shares of Amgen have risen 4.5% this year so far against a 1.2% decrease registered by the industry during this period.
Amgen has a total of 10 biosimilars in its portfolio. It has collaborated with Allergan for the worldwide development and commercialization of four oncology antibody biosimilar medicines including Rituxan. Last month, Amgen and Allergan (AGN) launched Mvasi and Kanjinti, biosimilar versions of Roche’s blockbuster medicines, Avastin and Herceptin, respectively in the United States. While Kanjinti is marketed in EU as well, Mvasi is approved in EU but not yet launched.
Meanwhile, Amgen has been marketing Amgevita (biosimilar of AbbVie’s [ABBV] Humira) in the EU since October last year. Amjevita (trade name of Humira biosimilar in the United States), though approved in the country, is expected to be launched in 2023 per a settlement with AbbVie. A biosimilar version of Johnson and Johnson/Merck’s Remicade (ABP 710) is also under review in the United States (FDA decision expected in December) and EU while a biosimilar of Alexion’s Soliris (ABP 959) is in late state development.
Amgen expects to launch additional biosimilars in the second half/2020 across multiple geographies. Amgen has also tied up with Daiichi Sankyo for the commercialization of some biosimilars in Japan.
In 2019 so far, biosimilars have generated revenues of $137 million for Amgen, all from international markets, With Mvasi and Kanjinti launched in the United States, biosimilars revenues should be higher in the second half. Biosimilars could be an important long-term growth driver for the company, especially as its mature drugs like Enbrel, Aranesp, Epogen, Neupogen and Neulasta are facing an array of branded and biosimilar competitors.
Amgen currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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