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Teva and Amgen latest to submit trastuzumab biosimilars to US FDA for review

Dan Stanton

By Dan Stanton+

01-Aug-2017
Last updated on 01-Aug-2017 at 11:57 GMT2017-08-01T11:57:15Z

Image: iStock/frender
Image: iStock/frender

The US FDA has accepted submission of two further Herceptin (trastuzumab) biosimilars: ABP 980 developed by Amgen and Allergan, and Teva and Celltrion’s CT-P6.

Back in January , a tratsuzumab molecule developed by Indian drug firms Mylan and Biocon became the first biosimilar of Roche’s blockbuster anti-HER2 monoclonal antibody Herceptin to be accepted for review by the US Food and Drug Administration (FDA).

And last month an FDA committee voted unanimously in favour of its approval, paving the way for the first Herceptin biosimilar to arrive in the US.

But while Mylan is looking to take a slice of a market which raked in CHF 2.5bn ($2.6bn) for Roche last year , the firm may soon have to compete against a number of other competitors, including two more Herceptin biosimilars which were successfully submitted to the FDA for review this week: ABP980 and CT-P6.

ABP 980 is one of four oncology biosimilars being co-developed following a $400m collaboration inked in 2011 between Amgen and Allergan (then Watson Pharmaceuticals). The submission of the molecule is the second in the partnership to be sent to the FDA after a version of Avastin (bevacizumab) ABP 215 which has subsequently been recommended for approval.

The submission of CT-P6 meanwhile marks Teva’s first biosimilar breakthrough in the US after teaming up with Korean drugmaker Celltrion last October . The Israeli generics giant holds the North American commercialisation rights for CT-P6 and CT-P10 – a version of another Roche blockbuster, Rituxan (rituximab) – following the deal, worth $160m.

“We look forward to the opportunity to leverage Teva’s strong legacy and US commercial presence in oncology to bring additional biosimilar treatment options to patients,” Paul Rittman, SVP at Teva Oncology said yesterday. “With today’s announcement, we are one-step closer to doing so in the US.”

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