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Celltrion's infliximab biosimilar Remsima secures European approval in five indications

The subcutaneous (SC) formulation of Remsima, Celltrion’s biosimilar version of infliximab, has secured approval from the European Commission covering five indications, according to the company, including ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.

The approval means that Remsima SC will be available in 120mg doses to adult patients for the treatment of one of the above conditions, regardless of their body weight.

Europe approves first subcutaneous version of biosimilar infliximab

The European Commission has chosen to authorise Celltrion Healthcare’s Remsima SC, a biosimilar of infliximab and the first subcutaneous formulation of the therapy, it has emerged.

The therapy was approved in combination with methotrexate (MTX) for the treatment of active rheumatoid arthritis in adult patients who have seen inadequate response with disease-modifying anti-rheumatic drugs (DMARDs), including MTX, and additionally in patients with severe, active and progressive forms of the disease who have not been previously treated with MTX or other DMARDs.

Celltrion's subcutaneous infliximab biosimilar secures CHMP recommendation

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous version of Remsima (biosimilar infliximab), in the treatment of rheumatoid arthritis, it has emerged.

As a subcutaneous formulation, the therapy “has the potential to enhance treatment options…by providing high consistency in drug exposure and a convenient method of administration,” according to the manufacturer.

US court upholds ruling that J&J's Remicade patent is invalid

The US Court of Appeals for the Federal Circuit has judged that Johnson & Johnson’s patent for its best-selling arthritis drug Remicade (infliximab) is invalid, upholding a previous decision by the US Patent and Trademark Office (PTO) that the antibodies covered by the patent were already disclosed in an earlier patent.

J&J loses Remicade patent fight, pledges to continue fight against biosimilars

Johnson and Johnson has announced that it has lost in a patent dispute between biosimilar makers Celltrion and Hospira, relating to its autoimmune disease drug Remicade (infliximab).

Samsung Bioepis’ Remicade biosimilar set for CHMP verdict

Samsung Bioepis has confirmed that the European Commission’s scientific committee, the CHMP, is this week discussing the approval of its Remicade (infliximab) biosimilar.

If green-lighted, Samsung Bioepis’ drug - named Flixabi - would be the second biosimilar version of Janssen and MSD’s original to hit the European market, following Celltrion’s.

Napp launches biosimilar in UK

Napp image
Napp, Cambridge Science Park

Napp Pharmaceuticals has launched its own biosimilar version of an anti-TNF biologic in Europe paving the way for patient access to biological medicines in the UK.

The Cambridge-based company’s Remsima (infliximab) is an anti-inflammatory biological medicine licensed for the treatment of a range of illnesses including Crohn’s disease – a long-term condition that affects about 115,000 people in the UK.

Hospira launches biosimilar monoclonal antibody

Hospira image
Merck’s Remicade patent is set to expire shortly so Hospira expects to be able to launch in the UK very shortly, a spokesman told Pharmafile

Hospira has won the race to become the first company to launch a biosimilar version of an anti-TNF biologic, after launching its copycat of infliximab in major European markets.

Inflectra (infliximab) is launched today in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden - countries where infliximab is now off-patent.

Merck’s Remicade patent is set to expire shortly, and so Hospira expects to be able to launch in the UK ‘in the next few days or weeks’, Paul Greenland, vice president of biologics at Hospira UK told Pharmafile.

Abbott wins $1.7bn Humira case

Abbott's Humira (adalimumab)

Abbott has been saved from paying Johnson & Johnson $1.7 billion after a US appeals court quashed a patent dispute verdict over its arthritis drug Humira.

The US Court of Appeals for the Federal Circuit concluded the two companies embarked on “very different strategies” with their anti tumour necrosis factor alpha (TNF-a) drugs.

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