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LONDON, UK / ACCESSWIRE / August 28, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Biogen Inc. (NASDAQ: BIIB), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=BIIB. The Company announced on August 25, 2017, that the Company and its joint venture partner, Samsung Biologics, have received a marketing authorization for IMRALDI® (also known as SB5), an adalimumab biosimilar referencing Humira®, by the European Commission (EC). For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected ObsEva SA (NASDAQ: OBSV) for due-diligence and potential coverage as the Company reported on August 15, 2017, its financial results for Q2 2017 which ended on June 30, 2017 and also provided a business update outlining recent corporate progress and upcoming milestones. Tune in to our site to register for a free membership, and be among the early birds that get our report on ObsEva when we publish it.

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IMRALDI has been developed by Samsung Bioepis and is approved for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, and uveitis.

IMRALDI, Biogen's Third Anti-TNF Biosimilar to receive Marketing Authorization in EU

IMRALDI is the third anti-TNF biosimilar from Biogen to receive a marketing authorization in the European Union (EU), following the approvals of BENEPALI® and FLIXABI® in 2016.

Approval of BENEPALI® in January 2016 - On January 16, 2016, Samsung Bioepis was granted marketing authorization in the EU for BENEPALI®, an etanercept biosimilar referencing Enbrel®, for the treatment of adults with moderate to severe RA, psoriatic arthritis, non-radiographic axial spondyloarthritis, and plaque psoriasis.

Approval of FLIXABI® in May 2016 - On May 30, 2016, Samsung Bioepis received the approval of the EC for the marketing of FLIXABI®, an infliximab biosimilar referencing Remicade®, for the treatment of adults with RA, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Approval Marks Another Step in Transforming Lives of Patients with Chronic Autoimmune Conditions

Commenting on the approval, Jean-Paul Kress, EVP International and Head of Global Therapeutic Operations, Biogen, expressed that this decision marks another positive step in transforming the lives of people with chronic autoimmune conditions. He added that as the number of approved biosimilars continues to grow, so does the anticipated potential to increase physician choice and patient access to biologics.

IMRALDI Demonstrated Comparable Efficacy and Safety to Humira

Approval of the EC was based on a robust preclinical and clinical data package comparing IMRALDI with Humira, including the results from two head-to-head studies.

Phase-I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humira and a 52 week Phase-III, randomized, double-blind, multicenter study, in which IMRALDI demonstrated comparable efficacy, comparable safety, and immunogenicity to Humira in patients with moderate to severe RA despite methotrexate therapy.

Amgen won European Approval for First Copy of Humira in March 2017

As per the press release, the EC granted two marketing authorizations for Amgen's biosimilars for Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab), on March 23, 2017.

About Humira

Adalimumab, sold under the trade name Humira, is a medication used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, chronic psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis. Humira® is a registered trademark of AbbVie Biotechnology Ltd.

About Samsung Bioepis

Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, is a biopharmaceutical company focused on increasing patient access to high-quality medicines through the development of biosimilars.

About Samsung BioLogics

Founded in April 2011 and headquartered in Incheon, South Korea, Samsung Biologics is a joint venture between Samsung affiliate companies and Quintiles Transnational Corp., and is engaged in the research, development, and commercialization of bio-healthcare products worldwide.

About Biogen Inc.

Incorporated in 1978, Biogen is a multinational biotechnology company involved in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases worldwide. The Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has the first and only approved treatment for spinal muscular atrophy (SMA), and is at the forefront of research into new medicines for neurological and neurodegenerative conditions. Biogen is headquartered in Cambridge, Massachusetts.

Last Close Stock Review

On Friday, August 25, 2017, the stock closed the trading session at $285.06, marginally dropping 0.14% from its previous closing price of $285.45. A total volume of 900.47 thousand shares have exchanged hands. Biogen's stock price surged 13.66% in the last three months and 0.86% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have gained 9.13%. The stock is trading at a PE ratio of 18.72. At Friday's closing price, the stock's net capitalization stands at $60.35 billion.

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