Baxalta Inc. BXLT and Momenta Pharmaceuticals, Inc. MNTA announced that their biosimilar candidate M923 has met the primary endpoint in a pharmacokinetic study.
Baxalta initiated the trial in Feb 2015. The primary objective of the randomized (n=324), double-blind, three-arm, parallel group, single-dose study was to evaluate the pharmacokinetics of M923 in comparison to AbbVie’s ABBV blockbuster drug, Humira (adalimumab). The study also evaluated the safety, tolerability and immunogenicity of single doses of M923 given by injection. The safety profile and immunogenicity were found comparable to the reference product.
We note that the companies have collaborated to develop and commercialize M923. Humira is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis among others. The two companies expect this trial to support an approval of their biosimilar in both the U.S. and the EU.
Meanwhile, Baxalta initiated a randomized, double-blind, active-control, multi-center, global trial on M923 in Oct 2015 on patients suffering from chronic plaque psoriasis. The trial will compare the safety, efficacy and immunogenicity of M923 with Humira in chronic plaque psoriasis. Baxalta plans to submit the first regulatory application for marketing approval for M923 in 2017 and targets a commercial launch in 2018, assuming a potential approval.
Baxalta is also developing a biosimilar version of Amgen’s AMGN Enbrel for the treatment of rheumatoid arthritis and psoriasis. The candidate is currently in phase III.
A potential approval would be a big boost for both the companies as Humira generated sales of $10.3 billion in the first nine months of 2015. However, competition is stiff in the biosimilar space.
We remind investors that last month, Amgen announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of Humira. The application is Amgen’s first BLA submitted under the 351(k) biosimilar pathway.
While Baxalta sports a Zacks Rank #1 (Strong Buy), Momenta is a Zacks Rank #3 (Hold) stock.
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