Adalimumab Biosimilars will provide a cost effective treatment option for inflammatory diseases

 In Diseases, FDA, Pharmaceutical companies

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Tumor necrosis factor-alpha (TNF-alpha) is a central regulator of inflammation, and TNF-alpha monoclonal antibodies are proved to be effective in treating inflammatory disorders in which TNF-alpha plays an important pathogenetic role. Recombinant or modified proteins or biologics are an emerging class of therapeutic agents. Inhibition of TNF has proven to be an effective therapy for patients with rheumatoid arthritis and other forms of inflammatory diseases including psoriasis, psoriatic arthritis, and ankylosing spondylitis, inflammatory bowel disease. The currently available therapies include a chimeric monoclonal antibody, infliximab, and a fully human monoclonal antibody, adalimumab.

Competitors of Adalimumab

AbbVie’s blockbuster drug Adalimumab (Humira), is a biologic used to treat inflammatory diseases like rheumatoid arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. Adalimumab is a TNF-inhibiting and anti-inflammatory medication, first approved by the U.S. Food and Drug Administration (FDA) in december 2002 and by EU in September 2003. Scientific advancements have given us a way to treat these diseases, but that comes at an extremely high cost. For example, Biologic drugs for rheumatoid arthritis work for 2 out of 3 people, but the drugs are expensive; they cost about $1,000 to $3,000 a month.

The patent on Humira expired in the US in December 2016 and in Europe it will expire in April 2018. Many companies like, Biogen, Momenta Pharmaceuticals, Coherus, Pfizer, Boehringer and Sandoz are developing Humira biosimilars to provide cost effective treatment and are at different stages of development.  According to FDA “Biosimilars are a type of biological product that is approved because they are highly similar to an already FDA-approved biological product, known as the biological reference product and have been shown to have no clinically meaningful differences from the reference product”. Boehringer’s adalimumab biosimilar BI 695501 and various others showed good phase III results and are in the line of approval process. So who are the main competitors: Boehringer’s BI 695501, Amgen’s ABP-501, Sandoz’s GP-2017, Kirin’s FKB-327, Momenta’s M-923 or Merck KGaA’s MSB-11022.

Amjevita: Approved but waiting for marketing

Amgen’s Humira biosimilar Amjevita is little ahead in the race as it is already approved in the US in September 2016 and in March 2017 by EC, and Boehringer Ingelheim’s BI 695501 is currently under review by both the EMA and FDA. The EC approved Amgevita based on evidence supporting biosimilarity to adalimumab encompassing analytical, pharmacokinetic and clinical data, including results from two Phase III studies in moderate-to-severe rheumatoid and plaque psoriasis patients. The trials each met their primary endpoint showing no clinically meaningful differences to the reference product. Safety and immunogenicity were also comparable. Coherus Biosciences, Momenta Pharmaceuticals and Sandoz also have reported positive phase III data and are in the race for the approval. But due to some patent disputes around the adalimumab, it is possible that it could delay the biosimilar’s marketing in the US until 2018 or 2019. If it would happen then there’s a chance of more competition in the market at that time by Samsung Bioepis, Coherus or Kyowa Kirin’s biosimilar. So hopefully, patients would get cost effective treatment for inflammatory diseases very soon.

By Dr. Rupesh Tyagi
Senior Research Analyst, Science and Research @ Innoplexus

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