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Baxalta, Momenta Begin Pivotal Study on Biosimilar of Humira

Baxalta IncorporatedBXLT is the latest company to join the race for biosimilars. The company along with Momenta Pharmaceuticals, Inc. MNTA announced the commencement of a pivotal study on their biosimilar candidate, M923, in patients suffering from chronic plaque psoriasis. The companies are developing M923 as a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira (adalimumab). Momenta's shares were up 3.5% on the news.

The randomized, double-blind, active control, multi-center study will be conducted to compare the safety, efficacy and immunogenicity of M923 with Humira. If all goes well, the companies intend to file for approval in 2017 and potentially launch the candidate in 2018.

We note that Humira is approved for the treatment of patients with autoimmune/inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis. According to an Evaluate Pharma report (8th Edition - Jun 2015), Humira was the top-selling product in 2014 with the drug generating worldwide sales of approximately $13 billion.

We remind investors that Baxalta is collaborating with Momenta for the development and commercialization of M923. In addition, Baxalta is developing a biosimilar version of Amgen Inc.'s AMGN Enbrel. The candidate is currently in phase III development for rheumatoid arthritis and psoriasis.

We are encouraged by the company's progress with M923. According to sources, the market for biosimilars can grow to $20 billion in 2020. Not surprisingly, pharmaceutical and biotech companies are racing to develop biosimilars.

Both Baxalta and Momenta are Zacks Rank #3 (Hold) stocks. Amgen is a better-ranked stock in the biotech sector carrying a Zacks Rank #1 (Strong Buy).

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AMGEN INC (AMGN): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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