FDA OKs and EMA Advisory Committee Recommends Remicade Biosimilar

The US Food and Drug Administration (FDA) has approved Inflectra (infliximab-dyyb) for multiple indications, and a biosimilar to Janssen Biotech, Inc.'s Remicade (infliximab). Inflectra is manufactured by Celltrion, Inc, based in Yeonsu-gu, Incheon, Republic of Korea, for Hospira (now part of Pfizer following Pfizer’s $17 billion acquisition of Hospira in 2015). Remicade is marketed by Johnson & Johnson’s Janssen Biotech, Inc., based in Horsham, Pennsylvania. Remicade was one of Johnson & Johnson’s top-selling pharmaceuticals with global 2015 sales of $6.56 billion.

Remicade (infliximab) was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of: adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis (arthritis of the spine); patients with active psoriatic arthritis; and adult patients with chronic severe plaque psoriasis.

Inflectra is the second biosimilar approved by the FDA. The first was Sandoz’s Zarxio (filgrastim-sndz), which was approved in March 2015 and is based on the reference product, Neupogen, marketed by Amgen, which was originally licensed in 1991. Zarxio was approved for the same indications as Neupogen, and can be prescribed by a healthcare professional for: patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia.

In other news, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorization of Flixabi (infliximab), an infliximab biosimilar candidate referencing Remicade. The biosimilar was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen. The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). If approved by the EC, Flixabi could be prescribed in the same indications as Remicade. This includes treatment of adults with rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Flixab could also be used in patients six to 17 years old with severe, active Crohn's disease or severely active ulcerative colitis.

The positive CHMP opinion comes shortly after marketing authorization was granted for Benepali (etanercept), a biosimilar referencing Enbrel, and like Flixabi, also an anti-TNF therapy.

Source: US Food and Drug Administration and Biogen

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