Pfizer has reported positive results from a trial of its monoclonal antibody PF-06410293, which the firm is developing as a biosimilar of AbbVie’s blockbuster Humira.
The drug giant said the REFLECTIONS B538-02 study met its primary endpoint by demonstrating that the therapy’s eff
icacy was equivalent to Humira (adalimumab) – as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12 – in patients with moderate to severe rheumatoid arthritis.
PF-06410293 is the second proposed inflammation biosimilar and the third proposed biosimilar pipeline molecule to report positive top-line results within the past four months, Pfizer noted.
Humira, an anti-TNF monoclonal antibody, pulls in annual sales of nearly $15 billion across its range of indications for inflammatory diseases.
It is currently approved in the US, EU and other markets for multiple indications including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
US regulators issued a green light for the first biosimilar of AbbVie’s biologic – Amgen’s Amjevita – in September last year.
