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

By Dan Stanton contact

- Last updated on GMT

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.”

Related topics: Markets & Regulations, Biosimilars

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