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Momenta drops Humira biosimilar development Posted 30/08/2019


Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they reported that they will stop the development of their Humira (adalimumab). However, they will continue to develop other biosimilar products.

Momenta’s M923 was underdevelopment as a biosimilar to AbbVie’s Humira. In 2018, this originator biological drug had sales of US$20 billion and was the largest selling medicine worldwide. However, in the US, due to legal issues between AbbVie and biosimilar producers, biosimilars will be prevented from entering the market until 2023 [2] and at this time, a host of other adalimumab biosimilars will enter the market meaning it could quickly become saturated.

Momenta will put the US$100 million it was going to spend on launching M239 into other biosimilar products. GlaxoSmithKline (GSK) was to be the supplier of M923 and Momenta has incurred charges payable to GSK as it has cancelled its 2020 manufacturing runs and may not use manufacturing runs scheduled for 2021 and 2022.

In their announcement, Momenta noted that the US Food and Drug Administration (FDA) approved generic versions of Copaxone 20 mg and 40 mg, under the product name Glatopa which was developed and commercialized in collaboration with Sandoz. They have recorded US$3.3 million in product revenue from Sandoz’s sales of Glatopa products.

In addition, M710 a proposed biosimilar to Eylea (aflibercept) will continue to be developed in collaboration with Mylan. At present, Mylan is continuing its phase III clinical trial of M710 in patients with diabetic macular oedema to compare safety, efficacy and immunogenicity with Eylea. It is expected that this product may be ready for launch in 2023. Also, over the next 12 to 15 months, they anticipate key readouts from other biosimilar candidates, including data from phase II studies of nipocalimab in generalized myasthenia gravis and M254 in Immune Thrombocytopenic Purpura.

Back on 1 October 2018, Momenta announced that it would be focusing on two key biosimilars and quit the development of five others [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Momenta to reduce its biosimilars programmes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 30]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. AbbVie makes more deals delaying adalimumab biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 30]. Available from: www.gabionline.net/Pharma-News/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-the-US

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