Blockbuster biosimilar competitors filed in US and EU

Two major new biosimilars have been unveiled in the space of a few hours, with Samsung Bioepis and Novartis filing copies of blockbuster monoclonal antibody drugs in the US and EU.

Samsung has filed SB2, a biosimilar of Johnson & Johnson/MSD’s Remicade (infliximab) in the US for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Meanwhile Novartis’ Sandoz biosimilars and generics unit has filed its version of Roche’s blood cancer drug, MabThera (rituximab).

Biosimilars are near-copies of biologic drugs, and are increasingly challenging the exclusivity of these hard-to-manufacture molecules. Biosimilars are big business, and a big opportunity for healthcare systems: infliximab, rituximab, and other big-selling drugs could save US and EU health systems up to $110 billion by 2020, according to a recent IMS Health report.

Rituximab is used to treat non-Hodgkin’s lymphoma, including follicular lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukaemia and autoimmune diseases such as rheumatoid arthritis.

Sandoz is seeking approval for the same indications as the reference product.

US sales of Remicade topped $4.4 billion in 2015, an increase of 7.2% compared with 2014 – but J&J has said it does not expect a biosimilar to launch this year.

J&J’s vice president of investor relations, Louise Mehrotra said last month that the company would defend US patents on the drug lasting until 2027, including the main patent 471 which lasts until 2018.

Samsung’s Remicade biosimilar was given the green light by Europe’s CHMP at the beginning of April, meaning approval by the European Commission is likely over the coming weeks.

The European patent on MabThera has already expired, but in Europe last year sales were 1.8 billion Swiss francs (£1.2 billion) as no biosimilar has yet been approved.

South Korea’s Celltrion has already filed its rituximab biosimilar in Europe in November.

Sandoz’s biosimilar adds to a long list of biosimilars under review in Europe, including two versions of AbbVie’s Humira (adalimumab), the world’s biggest selling drug.

There are around 20 biosimilars approved in Europe over the last 10 years, but only three approved by the US Food and Drug Administration, which has been slower to implement an approval pathway.

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