A Look at Amgen's Long-Term Growth Drivers

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Part 3
A Look at Amgen's Long-Term Growth Drivers PART 3 OF 6

Biosimilars Could Boost Amgen’s Revenue Growth

Recent collaborations

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.

Biosimilars Could Boost Amgen’s Revenue Growth

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Recent approval

In September 2017, the FDA approved Amgen’s (AMGN) and Allergan’s (AGN) Mvasi, a biosimilar to Roche’s (RHHBY) Avastin. The FDA has approved Mvasi for all indications for Avastin. 

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.

Amgen’s peers in the biosimilars drugs market include Hospira (a subsidiary of Pfizer), Mylan (MYL), Teva Pharmaceuticals (TEVA), and Sandoz (a subsidiary of Novartis). 

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.


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