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Published on 15 August 2014

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First biosimilar monoclonal antibody distribution licence secured

Mundipharma International Corporation Limited has announced that it has secured a distribution licence from Celltrion Healthcare Hungary Kft for RemsimaTM (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.

Mundipharma International Corporation Limited has announced that it has secured a distribution licence from Celltrion Healthcare Hungary Kft for RemsimaTM (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 a medicinal product containing a monoclonal antibody called infliximab. It 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).(1) 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 (100mg infliximab per vial) are also the same.(1) Remsima is therefore indicated for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult and paediatric Crohn’s disease and adult and paediatric ulcerative colitis.(1)

Double-blind randomised clinical trials involving 856 patients with active rheumatoid arthritis or ankylosing spondilitis in 29 countries and 146 sites were undertaken as part of the comparability exercise between Remsima and the reference infliximab product.(2,3) As a result of thorough research, it has been demonstrated via quality, non-clinical and clinical data that all major physicochemical characteristics and biological activities of Remsima were comparable to those of the originator infliximab product.(1)

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.”

 

References

  1.  Committee for Medicinal Products for Human Use (CHMP) summary of positive opinion for Remsima, (EMA/CHMP/363689/2013). 27 June 2013.
  2.  Yoo DH et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72:1613–20.
  3.  Park W et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013;0:1–8.


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