Amgen/Allergan's Avastin Biosimilar Secures EU Approval

Amgen, Inc. (NASDAQ:AMGN) and partner Allergan (NYSE:AGN) announced that the European Commission has granted marketing approval to its biosimilar version of Roche’s (OTC:RHHBY) blockbuster cancer drug, Avastin (bevacizumab), Mvasi. The drug was approved in the United States in September.

Mvasi is approved in the EU for the treatment of multiple types of cancer. Note that Mvasi is the first bevacizumab biosimilar to be approved in the European Union.

The approval was in line with expectations considering the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) had rendered a positive opinion for the approval of Mvasi in November/

The approval was supported by a comprehensive data package that demonstrated similarity of Mvasi with bevacizumab.

Amgen has collaborated with Allergan for the worldwide development and commercialization of four oncology antibody biosimilar medicines. Other than Mvasi, Amgen/Allergan’s portfolio also includes biosimilar versions of Herceptin (under review in the United States and EU) and Rituxan (in late stage studies)

Overall, Amgen has 10 biosimilars in its pipeline including biosimilar versions of Johnson and Johnson/Merck’s Remicade and Alexion’s Soliris. Amgen’s biosimilar version of Abbvie’s (NYSE:ABBV) blockbuster rheumatoid arthritis drug Humira, Amjevita, was approved by the FDA in September 2016 and in the EU (trade name: Amgevita) in March 2017 for the same indications as Humira.

Amjevita is the first biosimilar version of Humira to be approved by the FDA as well as Amgen’s first biosimilar medicine to be approved. Per a settlement agreement with AbbVie, Amgen will begin selling Amjevita in most countries in the EU this year and in the United States from January 2023.

Amgen’s biosimilar opportunity is likely to translate into annual revenues of more than $3 billion. Amgen has also partnered Daiichi Sankyo for the commercialization of nine biosimilars in Japan.

In the past year, Amgen’s shares have returned 21.3% compared with 4.2% increase registered by the industry.

Amgen carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

Will You Make a Fortune on the Shift to Electric Cars?

Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.

With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.

It's not the one you think.

See This Ticker Free >>