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Novartis gets FDA panel backing for biosimilar Enbrel

However Amgen claims patent protection for the psoriatic arthritis therapy is valid until 2029
Novartis

An FDA advisory committee has recommended approving Novartis' biosimilar version of Amgen's $5bn blockbuster Enbrel in the US.

The panel voted 20 to zero in favour of the GP2015 biosimilar for all five of TNF blocker Enbrel's approved indications - rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis.

The recommendation came just after Amgen secured a positive vote for a biosimilar of AbbVie's rival TNF inhibitor Humira (adalimumab), setting up greater competition in what is currently the pharma industry's largest product category by sales value.

Just how quickly the biosimilar can be brought to market remains a big question, however, as Amgen is still claiming patent protection for its drug in the US market out to 2029. The US biotech sued Sandoz in March, claiming that GP2015 infringes its US patents and is seeking an injunction on sales even if the FDA approves it.

Outside the US - where Pfizer holds rights to Enbrel - the drug is already facing biosimilar competition. Samsung Bioepis - a joint venture between South Korea's Samsung and Biogen - bagged EU approval for their Benepali biosimilar in January and has already launched it in several markets, while GP2015 is also under review by the EMA.

The GP2015 recommendation also puts Novartis on course for a second biosimilar approval in the US after its Zarxio product, a copy of Amgen's white blood cell stimulator Neupogen (filgrastim) was launched last year.

The company has several other biosimilars in clinical development, including copycat versions of Humira, Roche's MabThera/Rituxan (rituximab), Amgen's Epogen (epoetin alfa) and Neulasta (pegfilgrastim) and Johnson & Johnson's Remicade (infliximab).

Amgen teams up with Daiichi in Japan
Meanwhile, Amgen has firmed up its plans to launch biosimilars on the international stage via an agreement with Japan's Daiichi Sankyo.

The Japanese drugmaker gains exclusive commercialisation rights to nine drugs in Amgen's biosimilar pipeline, including its Humira clone and copies of Roche's anticancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab).

Amgen will remain responsible for the development and manufacturing of the biosimilars, while Daiichi Sankyo will file for marketing approval and will sell the drugs. The US biotech says it will also have 'limited rights' to co-promote the drugs.

Article by
Phil Taylor

14th July 2016

From: Regulatory

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