Biogen’s Humira Biosimilar Imraldi Gets Approval in EU

Biogen Inc. BIIB announced that its biosimilar version of AbbVie, Inc.’s ABBV top-selling blockbuster drug, Humira has been approved by the European Commission. The biosimilar will be marketed by the trade name of Imraldi.

Imraldi (or SB5) will be used for a whole range of indications including rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa and non-infectious uveitis.

We remind investors that the biosimilar was granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in June this year.

Biogen has a joint venture with Samsung BioLogics for biosimilars. Samsung Bioepis, the joint venture between the two companies, already marketsa couple of biosimilars in the EU – Flixabi (a biosimilar referencing J&J/Merck & Co., Inc.’s [MRK] Remicade) and Benepali (a biosimilar referencing Amgen/Pfizer’s Enbrel). This makes Imraldi the third anti-TNF biosimilar from Biogen to receive a marketing authorization in the EU.

Benepali is doing quite well, generating sales of $154 million in the first half of 2017 while Flixabi recorded sales of $2.5 million in the same period.

We note that earlier this year, Amgen, Inc. AMGN gained EU approval for Amgevita, its biosimilar version of Humira.

Biogen’s shares have risen 0.6% this year so far while the industry recorded an increase of 7.9%.

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

4 Surprising Tech Stocks to Keep an Eye On

Tech stocks have been a major force behind the market’s record highs, but picking the best ones to buy can be tough. There’s a simple way to invest in the success of the entire sector. Zacks has just released a Special Report revealing one thing tech companies literally cannot function without. More importantly, it reveals 4 top stocks set to skyrocket on increasing demand for these devices. I encourage you to get the report now – before the next wave of innovations really takes off.

See Stocks Now>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

To read this article on Zacks.com click here.

Zacks Investment Research