Mundipharma signs license agreement for Remsima in EU

August 15, 2014 12:41 PM

Mundipharma International Corporation Limited announced that it has secured a distribution license from Celltrion Healthcare Hungary Kft for Remsima (infliximab).

Following expiry of the relevant patents and Supplementary Protection Certificate’s, Mundipharma and its independent associated companies will have exclusive rights to market Remsima in the UK, Germany, Italy, Belgium, Luxembourg and the Netherlands.

Remsima is the first biosimilar monoclonal antibody (mAb) to be recommended for authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The therapeutic indications as well as the dosing regimen for Remsima are the same as those of the reference infliximab product Remicade; the pharmaceutical form (powder for concentrate for solution for infusion) and strength (100 mg infliximab per vial) are also the same. Remsima is therefore indicated for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult and paediatric Crohn’s disease and adult and paediatric ulcerative colitis.

Antony Mattessich, Managing Director Mundipharma International Limited said: “This addition to our portfolio is an exemplification of our aim to work in partnership with companies that share our high standards to deliver effective treatment options which meet the needs of both patients and payers. Thanks to our European reach, strong commercial focus and expertise, the strength of the Mundipharma independently associated companies is an attractive proposition to potential partners and we envisage increased expansion over the next decade with inflammation, respiratory, pain and oncology products as the focus of our growth.”

He continued: “We are excited to enter into this agreement with Celltrion, a leader in the development of biosimilars. We expect biosimilars to play an increasingly important role in providing cost effective treatments that enable broad access to effective treatments and are looking forward to introducing competition to an area that has historically been unhealthily short of it.”

Source: Mundipharma press release

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