Shire Ends Humira Biosimilar Program, Returns Candidate to Momenta
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Shire has decided to terminate its collaboration with Momenta Pharmaceuticals, a Cambridge, Massachusetts-based biotechnology company, to develop and commercialize M923, a proposed biosimilar referencing AbbVie’s Humira (adalimumab), an anti-tumor necrosis factor (TNF) monoclonal antibody that is approved for multiple indications. Shire’s decision to terminate the collaboration was based on a portfolio assessment following its acquisition of Baxalta in June 2016.

Under the collaboration formed in 2011, the agreement will terminate twelve months following the notice. Shire will continue to fund the M923 program until termination and will begin to transfer all ongoing clinical, regulatory and commercialization activities to Momenta.

Humira is AbbVie’s leading product, with global net sales of $14 billion in 2015. In September 2016, the US Food and Drug Administration approved Amgen’s Amjevita (adalimumab-atto), a Humira biosimilar, across all eligible indications of the reference product.

Source: Momenta Pharmaceuticals

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