Momenta Pharmaceuticals (MNTA, Financial) announced yesterday that the results from the “confirmatory, randomized, double-blind, multicenter study of M923 in adult patients with moderate-to-severe chronic plaque psoriasis” are equivalent to AbbVie's (ABBV, Financial) Humira in terms of the therapy’s efficacy, safety and body’s immune response after a treatment period of 16 weeks.
The total treatment was up to 48 weeks and the therapy was based on the administration of M923, Humira or Humira interchanged with M923.
For the development of M923, Momenta Pharmaceuticals closely worked with Baxalta, a biopharmaceutical company that was recently absorbed by Shire PLC (SHPG, Financial).
Momenta Pharmaceuticals says that the equivalency used to evaluate the biosimilarity of M923 to AbbVie’s Humira consists of the number of patients who achieved the same rate of symptoms’ improvement: “at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment.”
The Psoriasis Area and Severity Index, PASI, is a tool used by dermatologists to assess the severity and the largeness of the body’s area affected by the disease.
Baxalta also says that M923 achieved PASI-90, a proportion achieving clear or near-clear skin, and a change from baseline in absolute PASI score.
It is a very important step for Momenta Pharmaceuticals in its commitment to address the needs of patients with rare diseases and improve the quality of their lives.
It is important to remember that M923 is proposed as a biosimilar of Humira and not as an interchangeable product. As a biosimilar product, it could take some time, possibly years, before M923 is widely known by dermatologists and competes with Humira.
Biosimilar product means that M923 is “highly similar to an already FDA-approved biological product” (in this case AbbVie’s Humira) and has “shown to have no clinically meaningful differences from the reference product,” according to the Food and Drug Administration.
Having no meaningful differences from the reference product means M923 is not identical to Humira in terms of clinical results. In addition, the company says that the data on the M923’s adverse events are “comparable in terms of type, frequency and severity” and “consistent with the published safety data for Humira.” Thus, the data on M923’s adverse events are not identical to those of AbbVie’s Humira.
Momenta Pharmaceuticals is trading at $14.05 and has a market capitalization of $1.01 billion.
AbbVie is trading at $61.58, down two cents (or -0.03%) from the previous trading day. The stock is traded on the New York Stock Exchange and has a market capitalization of $103.66 billion.
Approximately 60% of AbbVie’s revenue comes from the sale of Humira. Because of the differences explained between a biosimilar and an interchangeable product, AbbVie’s shareholders should not be concerned about the existence of other Humira biosimilars.
Furthermore, Momenta Pharmaceuticals’ study covers only one of the diseases included in the spectrum of illnesses treated by Humira.
Disclosure: I have no positions in any stock mentioned in this article.
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