Lower-cost biotech drug gets thumbs up from FDA panel

An FDA panel unanimously endorsed Amgen’s (AMGN) biosimilar version of AbbVie’s (ABBV) blockbuster immunology drug Humira late Tuesday, making approval likely though it’s not clear when it will launch.

However, even if the advisory committee supports the drug’s approval and the FDA follows its advice, there could be a delay to GP2015’s launch in the U.S. as Amgen is suing Sandoz on grounds that its biosimilar infringes several of Enbrel’s patents. Enbrel competes with top-selling Humira, made by AbbVie Inc. It works by blocking a protein known as tumor necrosis factor, or TNF, and is approved for a number of conditions, including rheumatoid arthritis, psoriasis and psoriatic arthritis.

Humira is now the world’s best-selling drug, taking in some $14 billion worldwide past year, so AbbVie has been vigorously defending its intellectual property against Amgen and other challengers in court.

Food and Drug Administration staff called the injection from Novartis “highly similar” to Enbrel to treat five chronic inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, according to a report released Monday.

The review found that the company had also provided an extensive data package to address scientific considerations to support biosimilarity to other conditions for which Enbrel is approved.

And like Amgen’s Humira biosimilar, FDA staff said Sandoz “has also provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use to support their request that GP2015 should receive licensure for each of the indications for which US-licensed Enbrel is now licensed and for which GP2015 is seeking licensure”.

Even if the FDA approves the drug, it could be some time before it reaches the market.

The news from FDA on its advisory panel comes as in January, the European Commission signed off on an Enbrel biosimilar from Samsung Bioepis.

Analysts had expected approval of both the Amgen and Novartis biosimilars.