Samsung seeks 'interchangeable' label for Humira biosimilar


While there are already a number of biosimilars of AbbVie's big-selling Humira on the US market, so far, only one – Boehringer Ingelheim's Cyltezo – is interchangeable with the original, a coveted status that allows it to be switched for the brand without prescriber intervention.

Now, Samsung Bioepis and marketing partner Organon have the clinical data they need to get their Hadlima biosimilar approved as an interchangeable option and seek a leg-up in the competitive market for the lower-priced copycat therapies.

Hadlima – also known as SB5 – was one of several Humira biosimilars that launched in the US on or after 1st July, when AbbVie's patent protection for Humira (adalimumab) finally expired. The first to reach the market was Amgen's Amjevita back in January, which was able to launch early as a result of a patent litigation settlement with AbbVie.

Sales of Amjevita have so far remained relatively modest at $51 million in the first quarter of this year (Amgen is scheduled to report its second-quarter figures tomorrow), and with several other options now available further growth could be hard to come by.

Humira sales hit a high of $21 billion last year after more than a decade of $10 billion-plus growth, but have already shown signs of weakness overseas where biosimilars have been available for a while. Earlier this year, the company and are predicted sales of the immunology blockbuster will fall more than a third this year now that multiple biosimilars are available in the US.

Boehringer and Samsung Bioepis/Organon reckon that interchangeability will be the key to raising their biosimilar brands above the crowd. At the moment, other than Cyltezo all the Humira biosimilars require a physician to write a prescription specifically for them.

To try to change that, Samsung Bioepis and Organon have completed a phase 4 study involving 371 patients with moderate to severe chronic plaque psoriasis.

It compared one group that switched multiple times between Humira and Hadlima to a group that received AbbVie's drug continuously, and showed that the two groups were equivalent across a range of pharmacokinetic measures, as well as efficacy, safety, and immunogenicity profiles.

Organon launched Hadlima in July at an 85% discount to the brand, with a list price of $1,038 per carton containing two pre-filled pens or syringes. Other biosimilars that launched at the same time included products from Sandoz, Celltrion, Biocon, Pfizer, Coherus, and Fresenius Kabi.

Back in April, pharmaphorum's editor-in-chief, Jonah Comstock, spoke with Goodroot's CEO, Mike Waterbury, and Nuwae Health's CEO, Ralph Pisano. They discussed the availability of Humira biosimilars, which, according to Goodroot's research, is unlikely to actually lower prices very much.

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