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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.

Takeda jettisons non-core portfolio in Asia Pacific to Celltrion for a potential $278 million

Takeda continues its mission to reduce its debt in the wake of its $49 billion acquisition of Shire in January last year, announcing that it will sell a portfolio of non-core over-the-counter and prescription therapies to South Korea-based Celltrion in a deal worth up to $278.3 million.

The deal breaks down into an upfront payment from Celltrion of $266 million in cash, plus another potential $12 million in legal and regulatory milestone payments.

FDA greenlights Celltrion HIV drug manufacturing facility in South Korea

South Korean biopharma firm Celltrion has revealed that one of its key manufacturing facilities has been given the all-clear by the FDA following an on-site inspection in January.

The visit to the site in Cheongju, the largest city in the nation’s North Chungcheong Province, was for an additional inspection in order to review new technology which was omitted in the facility’s most recent Current Good Manufacturing Practice (CGMP) report, with the FDA finding no issues requiring intervention.  

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.

Top Ten most popular articles on Pharmafile.com this week!

Deals dominated this week as GSK and Pfizer announced that they would combine their consumer healthcare units in a collaboration worth billions. Meanwhile Japanese company Taisho revealed they were set to buy Bristol-Myers Squibb’s consumer healthcare business in a deal worth $1.6 billion. To top it off Swiss pharma giant Novartis signed a deal with Canadian cannabis company which propelled the latter’s stocks up by more than 11%.

Celltrion and Teva's Herceptin biosimilar secures FDA approval in breast cancer

Israeli and South Korean-based drug makers Teva and Celltrion are set to move in on the market share occupied by Roche and Genentech’s Herceptin (trastuzumab) with the announcement that their own biosimilar version of the drug has received approval from the FDA.

Herzuma, as the HER2/neu receptor antagonist biosimilar is known, was shown through a “comprehensive data package inclusive of foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data” to be clinically non-inferior to its reference product.

FDA approves first Rituxan biosimilar courtesy of Teva and Celltrion

The FDA has announced the first US approval of a biosimilar version of Genentech’s Rituxan (rituximab), awarding marketing approval to Celltrion and Teva’s Truxima.

The biosimilar is approved for three indications in adult patients:

Are biosimilars key to solving NHS access concerns?

Published on 01/10/18 at 12:15pm

In light of continued austerity gripping the NHS, it was uplifting to hear in July that the health service had generated millions in savings by switching to off-brand medications. Biosimilars formed a key part of this strategy, as Matt Fellows discovers.

The issue of drug pricing is an impassioned topic that, by its very nature, is impossible to divorce from issues of accessibility, whether that is concerned with payment through a nationalised health service, an insurer, or out of the patient’s own pocket.

Celltrion's Herceptin biosimilar seals EU approval

Herzuma, Celltrion’s biosimilar version of Roche/Genentech’s blockbuster immunotherapy Herceptin, has been awarded approval from the European Commission, the company has revealed.

The drug has been authorised in all of its reference product’s approved indications, which includes early breast cancer, metastatic breast cancer, or metastatic gastric cancer in patients whose tumours have either HER2 overexpression or HER2 gene amplification.

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