Alvotech, collaborators prep for Humira biosimilar launch in US

Quallent joins Teva in working to get Simlandi to patients after FDA OK

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by Lindsey Shapiro |

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Alvotech’s high-dose biosimilar of Humira (adalimumab) — a medication approved for ankylosing spondylitis (AS) and other inflammatory diseases — which was cleared by federal regulators earlier this year, will soon be launched in the U.S. under the brand name Simlandi.

A biosimilar is a medication containing the same active ingredient — in this case adalimumab — at the same dose as a brand-name biologic medication. While it’s deemed by regulators to be as safe and effective as the original, it usually comes at a lower cost. This is a similar concept to a generic medication, the difference being that generic is a term used for lab-made substances and biosimilar is used when referring to biologics, which are produced in living cells.

Alvotech has had an ongoing strategic agreement with Teva Pharmaceuticals since 2020 that expanded last year related to a number of Alvotech’s biosimilar treatment candidates, including Simlandi. The agreement stipulates that Alvotech handles development and manufacturing, while Teva is responsible for U.S. commercialization of the Humira biosimilar.

While that agreement remains intact, the companies now are bringing on board another partner, Quallent Pharmaceuticals, which will distribute the medication under a private label in the U.S., according to a press release from the three partners.

“We are pleased to be working with Alvotech to bring adalimumab-ryvk to more patients,” said John Caufield, Quallent’s president.

“Quallent was established to help pharmacies give their patients safe and affordable medication, and this collaboration will help us deliver on this goal … Our intent is to offer a copay assistance program, which will provide eligible patients access,” Caufield added.

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Amjevita, first Humira biosimilar, now available to AS patients in US

Simlandi Humira biosimilar granted interchangeability status at 40 mg dose

AbbVie’s Humira is an approved medication containing adalimumab, an antibody that blocks the activity of an inflammatory signaling molecule, called tumor necrosis factor-alpha (TNF-alpha), that’s implicated in a range of inflammatory diseases.

The medication is available in several strengths, which can be broadly categorized as high concentration or low concentration. According to Alvotech, nearly 88% of all prescriptions in the U.S. are for high-concentration formulations.

In adults with AS, the medication is given as a subcutaneous or under-the-skin injection once every two weeks at a dose of 40 mg. By helping ease inflammation in the joints of the spine, Humira helps relieve the symptoms of AS.

Simlandi is available at the 40 mg/0.4 mL concentration — one of the high-dose formulations — and is approved for use in all nine conditions for which Humira is approved. It’s also citrate-free, which is associated with less pain during injections.

The U.S. Food and Drug Administration has granted Simlandi what’s called interchangeability status. This means that a pharmacist can swap out the brand-name medication for the Humira biosimilar without having to consult the doctor who prescribed it, and there won’t be any differences in the effects of the medications.

While several other biosimilars for Humira were approved before it, Simlandi is the first high-concentration, citrate-free formulation to be granted interchangeability status at the 40 mg/0.4 mL concentration.

That enables it to hold interchangeability status exclusively for a year, meaning no other biosimilar at this concentration can be considered interchangeable during that time.

With our commercial partners for the U.S., we aim to increase healthcare access and ensure that affordable high-quality biologics are available to patients in need.

“Being able to obtain interchangeable exclusivity for the high-concentration formulation … has generated significant payor interest for this unique product in the U.S. market,” said Robert Wessman, chairman and CEO of Alvotech.

“With our commercial partners for the U.S., we aim to increase healthcare access and ensure that affordable high-quality biologics are available to patients in need,” Wessman added.

Elsewhere, Simlandi is also approved in Canada and Saudi Arabia, as well as in Europe under the brand name Hukyundra and in Australia as Ciptune and Ardalicip.