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Amgen and Allergan close on Avastin biosimilar filing

ABP 215 matches reference drug in study
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A biosimilar version of Roche's big-selling cancer drug Avastin, developed by Amgen and Allergan, has matched the reference drug in a phase III trial.

ABP 215 was shown to be equivalent to Avastin (bevacizumab) on both the safety and efficacy measures in the trial, which involved patients with the non-squamous form of non-small cell lung cancer (NSCLC).

Treatment included a screening period of up to four weeks followed by up to six treatment cycles (an intravenous infusion of 15 mg/kg every three weeks) and an end-of-treatment visit 21 days after the last dose of either ABP 215 or Avastin.

"NSCLC is the leading cause of cancer death in both men and women in the US and the EU [and] ABP 215 holds the potential to advance access to treatment options for oncology patients," commented Sean Harper, Amgen's executive vice president of R&D.

At the moment there are no approved biosimilars of Avastin, which is currently Roche's third-biggest product with sales of CHF3.26bn ($3.33bn) in the first six months of the year, fractionally behind breast cancer drug Herceptin (trastuzumab).

The reference product is approved to treat for first-line treatment in patients with advanced or recurrent non-squamous NSCLC in combination with platinum-based chemotherapy, as well as colorectal, kidney, cervical, ovarian and brain cancer.

ABP 215 is one of nine biosimilars, including four antibodies for cancer, that are being developed by Amgen and Allergan under an alliance originally started in 2011. Others include a biosimilar of AbbVie's arthritis therapy Humira (adalimumab) called ABP 501.

While biosimilars for first-generation protein drugs have been available in Europe and various other markets outside the US for several years, copies of more complex biologics such as monoclonal antibodies (mAbs) have only just started to appear.

In Europe the first biosimilar antibody to reach the market was Celltrion and Hospira's version of Johnson & Johnson's Remicade (infliximab), which has since also been launched in Canada, India and Japan and is also filed for approval in the US.

Meanwhile, biosimilars of other mAbs - including Herceptin, Humira, Amgen's arthritis drug Enbrel (etanercept) and Novartis/Roche's eye therapy Lucentis (ranibizumab) - have also started to appear in other world markets such as India, Russia and Korea.

The global biosimilars market is expected to grow to around $25bn by the end of the decade as drugs with sales of around $100bn lose patent protection, according to a recent report from Thomson Reuters.

Article by
Phil Taylor

24th September 2015

From: Research

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