We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Amgen Wins Favorable CHMP Opinion for Humira Biosimilar
Read MoreHide Full Article
Amgen Inc. (AMGN - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on the company’s marketing authorization application (MAA) for ABP 501, a biosimilar version of AbbVie Inc.’s (ABBV - Free Report) best-selling drug, Humira (adalimumab). This marks the first time that an adalimumab biosimilar has received a CHMP recommendation.
Amgen’s share price movement shows that the stock has outperformed the Zacks classified Medical-Biomed/Genetics industry year to date. Specifically, the company gained 7.5%, while the industry increased 2.1%.
ABP 501 was approved in the U.S. in Sep 2016 under the brand name Amjevita. It is approved for all indications of Humira, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis(AS), Crohn’s disease (CD) in adults, ulcerative colitis (UC), plaque psoriasis (PsO) – all in specific patient populations. Amjevita was the first biosimilar version of Humira approved by the FDA and Amgen’s first approved biosimilar. However, Amjevita has not been launched yet due to the ongoing litigation with AbbVie.
The MAA submission for ABP 501 was supported by comprehensive analytical, pharmacokinetic and clinical data. The filing also includes results from two phase III studies on moderate-to-severe PsO and moderate-to-severe RA. Both the studies met the primary endpoint, demonstrating no clinically meaningful difference with Humira. Safety and immunogenicity of ABP 501 was also comparable to the reference product.
Currently, Amgen has nine biosimilar candidates in its portfolio, representing annual revenues of more than $3 billion. The company is working on developing biosimilar versions of drugs like Avastin, Herceptin, Remicade, Rituxan and Erbitux. Amgen has collaborated with Allergan plc for the worldwide development and commercialization of four oncology antibody biosimilars.
However, Amgen is facing biosimilar competition in the U.S. Zarxio, the first FDA-approved biosimilar, was launched by Novartis AG’s (NVS - Free Report) generic arm, Sandoz, in Sep 2015. Zarxio is the biosimilar version of Amgen’s blockbuster drug, Neupogen. A couple of key drugs from Amgen’s portfolio – Neulasta and Enbrel – could also start facing biosimilar competition soon. Sandoz received approval for a biosimilar version of Enbrel, Erelzi, in Aug 2016. However, Erelzi is yet to be launched in the U.S.
Since the biosimilar market is highly lucrative, competition is intensifying with numerous pharmaceutical and biotech companies eyeing to foray into the space.
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>
See More Zacks Research for These Tickers
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Amgen Wins Favorable CHMP Opinion for Humira Biosimilar
Amgen Inc. (AMGN - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on the company’s marketing authorization application (MAA) for ABP 501, a biosimilar version of AbbVie Inc.’s (ABBV - Free Report) best-selling drug, Humira (adalimumab). This marks the first time that an adalimumab biosimilar has received a CHMP recommendation.
![](https://staticx-tuner.zacks.com/images/zadmin_tuner_image/amgn_2017_01_30.jpg)
Amgen’s share price movement shows that the stock has outperformed the Zacks classified Medical-Biomed/Genetics industry year to date. Specifically, the company gained 7.5%, while the industry increased 2.1%.
ABP 501 was approved in the U.S. in Sep 2016 under the brand name Amjevita. It is approved for all indications of Humira, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis(AS), Crohn’s disease (CD) in adults, ulcerative colitis (UC), plaque psoriasis (PsO) – all in specific patient populations. Amjevita was the first biosimilar version of Humira approved by the FDA and Amgen’s first approved biosimilar. However, Amjevita has not been launched yet due to the ongoing litigation with AbbVie.
The MAA submission for ABP 501 was supported by comprehensive analytical, pharmacokinetic and clinical data. The filing also includes results from two phase III studies on moderate-to-severe PsO and moderate-to-severe RA. Both the studies met the primary endpoint, demonstrating no clinically meaningful difference with Humira. Safety and immunogenicity of ABP 501 was also comparable to the reference product.
Currently, Amgen has nine biosimilar candidates in its portfolio, representing annual revenues of more than $3 billion. The company is working on developing biosimilar versions of drugs like Avastin, Herceptin, Remicade, Rituxan and Erbitux. Amgen has collaborated with Allergan plc for the worldwide development and commercialization of four oncology antibody biosimilars.
However, Amgen is facing biosimilar competition in the U.S. Zarxio, the first FDA-approved biosimilar, was launched by Novartis AG’s (NVS - Free Report) generic arm, Sandoz, in Sep 2015. Zarxio is the biosimilar version of Amgen’s blockbuster drug, Neupogen. A couple of key drugs from Amgen’s portfolio – Neulasta and Enbrel – could also start facing biosimilar competition soon. Sandoz received approval for a biosimilar version of Enbrel, Erelzi, in Aug 2016. However, Erelzi is yet to be launched in the U.S.
Since the biosimilar market is highly lucrative, competition is intensifying with numerous pharmaceutical and biotech companies eyeing to foray into the space.
Amgen Inc. Price
Amgen Inc. Price | Amgen Inc. Quote
Zacks Rank
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>