Sandoz’s Enbrel biosimilar approved in US

Sandoz’s Erelzi has become the first biosimilar of Amgen’s Enbrel (etanercept) blockbuster inflammatory diseases drug to gain FDA approval.

Erelzi (etanercept-szzs) has been approved in all uses included in the reference product label – allowing the Novartis unit to compete against a product that generates sales of more than $5 billion a year in the US alone.

Outside the US, Enbrel is marketed by Pfizer – but it also faces competition in Europe from another near-copy from Samsung Bioepis.

The US is lagging behind Europe in the field of biosimilars, which are near-copies of biologic drugs, and this is only the third such product approved by the FDA.

The majority of Enbrel’s sales are in rheumatology, as the drug is approved in indications including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile arthritis.

No details about pricing have been released by Sandoz yet, though it priced its first US biosimilar Zarxio at 15% discount to the originator drug Neupogen, another Amgen drug.

Sandoz gave no details about launch dates either, as like all originator companies, Amgen is likely to mount a legal defence against Erelzi, as manufacturers must wait for 180 days before launching the first biosimilar.

Pfizer will not be able to launch its biosimilar Remicade until October, six months after approval, under these regulations.

Sandoz has also filed the etanercept biosimilar with the European Medicines Agency, where the drug is currently under review.

In the three year period 2015-17, Sandoz plans 11 biosimilar filings, with six already completed.

IMS Health anticipates that biosimilars could save health systems in the US and the five largest EU countries up to $110 billion by 2020.

Carol Lynch, global head of biopharmaceuticals at Sandoz, said: “We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the healthcare system.”

The FDA has already approved Pfizer’s Inflectra (infliximab-dyyb) and Sandoz’s Zarzio (filgrastim-sndz), which are near copies of J&J’s Remicade inflammatory diseases drug and Amgen’s Neupogen white blood cell stimulator.

Last month, Sandoz revealed that the FDA had rejected its biosimilar of Amgen’s Neulasta (pegfilgrastim), a longer lasting version of Neupogen.

The FDA is set to make a decision over the coming weeks over Amgen’s biosimilar of AbbVie’s Humira (adalimumab), which is the world’s biggest selling drug – and approval is likely given that FDA advisers unanimously recommended approval in July.

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