The Center for Biosimilars Staff

The FDA has approved Sandoz’s biosimilar adalimumab, adalimumab-adaz (Hyrimoz) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis. 

In a prepared statement, Stefan Hendriks, global head of biopharmaceuticals for Sandoz, wrote, "Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease. With the 

, Sandoz is one step closer to offering US patients with autoimmune diseases the same critical access already available in Europe."

Sandoz submitted its Biologics License Application (BLA) for the adalimumab biosimilar in January of this year. The BLA included data from the phase 3 ADACCESS study in patients with moderate to severe chronic plaque psoriasis. 

Read more about the approval at the Center for Biosimilars website. 

Articles

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis. 

FDA OKs Biosimilar Adalimumab for Autoimmune Conditions

Richard G. Frank, PhD, a health economist at Harvard Medical School and the former deputy assistant secretary for planning and evaluation at HHS, has penned a new perspective paper in the New England Journal of Medicine in which he warns that, if biosimilars continue their trajectory, they could fail to deliver on their promise to provide cost savings to the US health system.

Frank points out that only an estimated $3.2 billion (3%) of US biologic drug spending is currently subject to competition from biosimilars. That is a disappointing figure given that spending on biologic drugs has been averaging a 10% annual increase recently.

So what’s holding biosimilars back? Frank says that physicians are “naturally hesitant” to prescribe biosimilars because they lack familiarity with these products, “especially given that regulations create the impression that a biosimilar may not be all that similar to its originator.” 

The United States has been slow to embrace biosimilars, which may impact the overall effect they have on prescription drug spending. 