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FDA panel backs Avastin and Herceptin biosimilars

A decision from the US regulator is expected in September

Herceptin

A US FDA advisory committee gave its blessing to two biosimilar versions of Roche's cancer antibodies Avastin and Herceptin yesterday, raising the prospect of cut-price competition to two of the company's biggest selling products.

Amgen and Allergan got a unanimous vote in favour of approving their biosimilar of Avastin (bevacizumab) in the morning yesterday, while Mylan and Biocon got the go-ahead in the afternoon for their Herceptin (trastuzumab) rival. In both cases, panellists concluded there were no clinically meaningful differences between the reference products and the biosimilars.

Amgen and Allergan's candidate is the first biosimilar of Avastin to reach this stage and the FDA is now scheduled to make a decision on the marketing application in September, although a launch will depend on the outcome of ongoing patent litigation with Roche.

Mylan meanwhile is also pitching at a September verdict for its drug, and recently agreed a settlement deal with Roche to clear the way for a US launch if approved by the FDA.

Avastin is indicated for a range of solid tumours and brought in $7bn in sales last year - almost $3bn from the US market. Meanwhile, sales of HER2-positive breast cancer therapy Herceptin also approached $7bn in 2016 with around $2.5bn from the US.

Roche may not have to worry too much however, at least in the short-term. Biosimilars do not tend to prompt the massive reduction in sales seen when generics are launched for traditional pharmaceuticals, as they are still costly to produce and so are generally priced at less of a discount.

Meanwhile, the Swiss group is in the midst of a fertile launch period for new medicines, with four new drugs - Cotellic (cobimetinib) for melanoma, Alecensa (alectinib) for lung cancer, leukaemia therapy Venclexta (venetoclax) and PD-L1 inhibitor Tecentriq (atezolizumab) for bladder and lung cancer - rolling out onto the market.

Of these, Tecentriq and Venclexta alone have been predicted to add nearly $4bn to Roche sales in 2021, according to a recent EvaluatePharma report, which should help offset a predicted $5.5bn reduction in global Herceptin and Avastin sales in 2022.

Article by
Phil Taylor

14th July 2017

From: Regulatory

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