Biosimilars Could Boost Amgen’s Revenue Growth
In September 2017, Amgen (AMGN) and Simcere Pharmaceuticals entered into a strategic collaboration to jointly develop and commercialize four biosimilars in China. By the terms of the agreement, Amgen would jointly develop biosimilars with Simcere Pharmaceuticals. It would also be responsible for marketing approval and manufacturing activities.
Simcere would carry out distribution and commercialization of the biosimilars in China. Amgen would have limited rights to market the products in China.
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The FDA has approved Mvasi for use in five different cancer types. Mvasi has been approved for use in combination with chemotherapy for non-squamous non-small cell lung cancer (or NSCLC), metastatic colorectal cancer (or mCRC), metastatic renal cell carcinoma (or RCC) in combination with interferon alfa, glioblastoma, and metastatic carcinoma of the cervix.
Presently, Amgen holds ten biosimilars in its product portfolio. Among the ten biosimilars in Amgen’s portfolio, two biosimilars have received FDA approval.
Clinical trial results
In September 2017, Amgen and Allergan presented results from the Phase 3 trial, which evaluated the safety and efficacy of ABP 980, a proposed biosimilar to Herceptin. It is comparable to the original product for the treatment of individuals with human epidermal growth factor receptor 2-positive (or HER2-positive) early breast cancer.
In the Phase 3 study, according to a central independent review, 47.8% of the patients in the ABP 980 wing achieved pathologic complete response. Plus, 41.8% of the patients in the trastuzumab therapy wing achieved a pathologic complete response.
The ABP 980 study results are presently under review by the European Medical Agency (or EMA) and the FDA. The approval of the biosimilar could strengthen Amgen’s biosimilar portfolio.
The growth in sales of Amgen’s biosimilars could boost the iShares Nasdaq Biotechnology ETF (IBB). Amgen makes up about ~8.6% of IBB’s total portfolio holdings.