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Amgen Gets FDA Approval for J&J/Merck's Remicade Biosimilar

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Amgen (AMGN - Free Report) announced that the FDA has granted approval to its biosimilar version of Johnson and Johnson (JNJ - Free Report) /Merck’s (MRK - Free Report) blockbuster immunology medicine, Remicade (infliximab). The biosimilar will be marketed by the trade name of Avsola (ABP 710) for all approved indications of Remicade, which includes a range of autoimmune disorders. ABP 710 is an anti-TNF monoclonal antibody. However, Amgen did not mention when it plans to launch Avsola.

The approval was based, in part, on data from a late-stage study, which evaluated ABP 710 versus branded Remicade, for the treatment of moderate-to-severe rheumatoid arthritis (RA). 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 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22.

ABP 710 is also under review in the EU. Pfizer (PFE - Free Report) was the first company to have launched a biosimilar version of Remicade, Inflectra in 2016. Merck/Samsung Bioepis also market Renflexis, a biosimilar of Remicade.

Amgen’s shares have risen 20.1% this year so far compared with 6.6% increase registered by the industry during this period.

Amgen boasts a strong biosimilars portfolio/pipeline, which could be an important long-term growth driver for the company. Amgen achieved several important milestones with its biosimilars portfolio in 2018/2019 including its first two launches in EU – Amjevita (biosimilar of AbbVie’s Humira) and Kanjinti (biosimilar of Roche’s Herceptin) as well as United States -  Kanjinti and Mvasi (biosimilar of Roche’s Avastin). In the United States, Amjevita is expected to be launched in the United States in 2023. Avsola is Amgen’s fourth biosimilar product to be approved in the United States. A biosimilar of Alexion’s Soliris (ABP 959) is in late state development.

Amgen’s biosimilars business is already annualizing at approximately $700 million in sales .Amgen expects to launch additional biosimilars in 2020 across multiple geographies.

Amgen has collaborated with Allergan for the worldwide development and commercialization of Mvasi, Kanjinti and biosimilar Rituxan (in late-stage development). Amgen has also tied up with Daiichi Sankyo for the commercialization of nine biosimilars in Japan.

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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