EMA, FDA Accept Filing for BI’s Biosimilar to Humira

Both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted for review Boehringer Ingelheim’s (BI) adalimumab biosimilar candidate to AbbVie’s Humira (adalimumab), designated as BI 695501, for which BI is seeking approval in the European Union and the US. Humira is AbbVie’s top-selling drug and is one of the top-selling drugs in the pharmaceutical industry with 2015 global sales of $14 billion.

Adalimumab is a monoclonal antibody that blocks tumor necrosis factor-alpha, a mediator of inflammation in the human body. Adalimumab is approved as a biologic medicine under the brand name Humira in many countries for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, inflammatory bowel disease, and psoriasis.

Other companies are pursuing biosimilars of Humira. Amgen’s Amjevita (adalimumab-atto) received approval from the FDA in September 2016 across all eligible indications of Humira. Amjevita was approved for treating seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn’s disease, and moderate-to-severe ulcerative colitis. Amjevita is also undergoing review by the EMA, following a regulatory submission in December 2015.

Several other companies are also developing biosimilars to Humira for various indications and which are in different stages of development, according to a May 2016 analysis by QuintilesIMS. These companies include: Baxalta with partner Momenta Pharmaceuticals (Phase III, psoriasis), Coherus Biosciences (Phase III, psoriasis), Epirus Biopharmaceuticals (discovery stage), Fujifilm Kyowa Kirin Biologics (Phase III, rheumatoid arthritis), Merck KGaA (Phase III, psoriasis), Oncobiologics (Phase I stage), Pfizer (Phase III, rheumatoid arthritis), and Sandoz (Phase III, psoriasis).

In addition to BI 695501, BI is also developing a bevacizumab biosimilar candidate, BI 695502, to Roche’s Avastin (bevacizumab). Avastin is Roche’s top-selling drug and one of the top 10 drugs in the pharmaceutical industry with 2015 sales of approximately CHF 6.68 billion ($6.68 billion)

Source: Boehringer Ingelheim

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