First Boehringer Ingelheim’s biosimilar drug is approved in Europe

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Boehringer Ingelheim announced that the European Commission has granted marketing authorisation for Cyltezo a biosimilar to Humira for the treatment of multiple chronic inflammatory diseases in adults and children.

Biosimilar from Boehringer Ingelheim has been approved for the treatment of multiple chronic inflammatory diseases in adults. It has also been granted marketing authorisation for the treatment of paediatric inflammatory diseases, including moderate to severe Crohn’s disease (age six and older), severe chronic plaque psoriasis (age four and older), enthesitis-related arthritis (age six and older) and polyarticular juvenile idiopathic arthritis (age two and older).

“Cyltezo® is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Boehringer Ingelheim has been an industry leader in the production of biologics for 35 years, and we are delighted to have applied this expertise to the development of Cyltezo®. We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.”

Biosimilar from Boehringer Ingelheim has been approved for the treatment of multiple chronic inflammatory diseases in adults. It has also been granted marketing authorisation for the treatment of paediatric inflammatory diseases, including moderate to severe Crohn’s disease (age six and older), severe chronic plaque psoriasis (age four and older), enthesitis-related arthritis (age six and older) and polyarticular juvenile idiopathic arthritis (age two and older).

The marketing authorisation of Cyltezo was based on a comprehensive data package supporting the biosimilarity of Cyltezo to Humira comprising analytical, pharmacological, non-clinical and clinical data.

Cyltezo is not commercially available in Europe or the U.S. at this time. In any event Boehringer Ingelheim does not intend to launch Cyltezo in the EU before expiration of the respective SPC (Summary of Product Characteristics) for adalimumab in October 2018. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S

SOURCE: business wire
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