How Much Revenues Does Roche Stand To Lose Given The FDA Nod For Pfizer’s Biosimilar For Avastin?

by Trefis Team
Roche Holdings
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  • Roche Holding’s (NASDAQ:RHHBY) oncology portfolio is its largest therapeutic area, and Avastin is one of its top selling drugs. However, it is expected to lose market exclusivity this year, and Pfizer’s Zirabev, a biosimilar to Avastin, was recently approved by the U.S. FDA, while it was already approved by the EU regulators. In this analysis, we look at other drugs, which were impacted after the biosimilars hit the market, and highlight Avastin’s possible loss of revenue over the next few years.  You can view our interactive dashboard analysis ~ How Much Revenue Can Roche’s Avastin Lose To Pfizer’s Biosimilar Zirabev? ~ for more details. In addition, look at our data for healthcare companies here.

Avastin Is An Important Drug For Roche, Accounting For 12% of The Company’s Total Sales In 2018

  • Avastin is Roche’s blockbuster drug used for the treatment of non-squamous, non-small cell lung cancer, and metastatic renal cell carcinoma, along with in combination therapy for breast and renal cancer.
  • Avastin was first approved by the U.S. FDA in 2004. The drug has seen strong growth with annual sales of around $7.0 billion in the recent years, representing close to 12% of the company’s total sales.

Roche’s Avastin Could Trend In-Line With Johnson & Johnson’s Remicade, Which Lost About $1.7 Billion In Sales Since The Loss of Market Exclusivity, While Inflectra Gained Over $600 Million During The Same Period

  • Johnson & Johnson’s blockbuster drug ~ Remicade’s ~ market exclusivity period has ended, and it has been facing biosimilar competition since 2016.
  • Pfizer’s Inflectra is the biosimilar for Remicade, which generated sales of $192 million in 2016, and they grew to $642 million in 2018.
  • Remicade’s sales dropped from around $7.0 billion in 2016 to 5.3 billion during the same period.
  • Roche’s Avastin decline could be in line with some of the other oncology drugs, including Gleevec and Velcade, which lost marketing exclusivity over the last few years.
  • While Takeda’s Velcade market exclusivity was valid till 2022, it was being challenged by Allergan, Novartis, and Accord Healthcare, and a district court struck down Velcade’s patent in a ruling in 2015. This led to a sharp decline in sales, in the following year. However, a higher court upheld Takeda’s patent in a ruling in 2017. We have used the 2015 incident to highlight the decline in sales in subsequent years.

We Estimate Avastin’s Sales Could Decline By $1 Billion Over The Next Few Years, While Pfizer’s Zirabev Will See Strong Sales Growth Over The Same Period

  • Avastin could see a decline of close to $1 billion in sales over the next few years, as it is expected to face biosimilar competition.
  • Avastin will lose market exclusivity in 2019, and face biosimilar competition from Pfizer’s biosimilar Zirabev, which has been approved by the U.S. FDA and the EU.
  • Pfizer’s Zirabev sales could grow to $180 million in 2019, and north of $600 million by 2021.

The Decline In Sales After Patent Loss For Any Drug Can Be Attributed To the Difference In Pricing

  • Novartis’ Gleevec was priced at $9,000, while its biosimilar was priced at $8,000 in 2017, reflecting an 11% lower price. This is one of the cases where the prices didn’t see any significant drop.
  • Teva’s Copaxone was priced at $5,800, while its biosimilar from Mylan was priced at 1,900 in 2018, reflecting a 67% lower price.
  • Biosimilars are usually priced at 30% or more discount to the patented drug’s price, which should be the case for Zirabev.



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