On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.
Pictured: FDA signage outside its office in Washington, DC/iStock, JHVEPhoto
The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.
Simlandi is the first high-concentration, citrate-free and interchangeable Humira biosimilar to be approved in the U.S., according to Alvotech’s announcement.
Like its branded reference product, Simlandi is authorized for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, uveitis and hidradenitis suppurativa. With the FDA’s interchangeability designation, Simlandi can also be substituted for Humira at the pharmacy without needing to change the prescription or consulting the prescribing physician.
Alvotech CEO Robert Wessman in a statement said that Simlandi’s approval is an important development “in addressing inflationary pressures in the healthcare system,” especially in the U.S. “An interchangeable, citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.,” Wessman contends.
Friday’s regulatory win was based on analytical, non-clinical and clinical data backing Simlandi. These include one Phase I study, demonstrating the pharmacokinetic similarity between Simlandi and Humira, and two Phase III randomized trials in moderate-to-severe plaque psoriasis—both of which show the overall efficacy and safety of the biosimilar compared to its branded reference.
Following the approval, Alvotech and Teva are working to launch Simlandi in the U.S. “imminently” with its interchangeability designation, the companies said.
When it launches, Simlandi will face off against other Humira copycats, including Amgen’s Amjevita, Celltrion’s Yuflyma and Boehringer Ingelheim’s Cyltezo, which is also an interchangeable biosimilar.
Despite having some significant discounts compared to the branded product, the biosimilars that first became available in the U.S. in 2023 have largely been unable to shake AbbVie’s tight grip on the market, with Humira ceding only 2% of its market share, according to a report last month from Samsung Bioepis.
Friday’s FDA approval represents the culmination of what has been a long and tough regulatory journey for Simlandi. In April 2023, the regulator denied to approve the Humira biosimilar, citing manufacturing issues at its Reykjavik, Iceland facility. Alvotech got slapped with another Complete Response Letter in June 2023, when the FDA rejected its bid for the interchangeability designation.
The regulator inspected Alvotech’s manufacturing plant in Iceland in March 2022 and subsequently issued a warning letter, which identified several quality control problems including an “unacceptably high number of mold recoveries” in rooms that were supposed to be used for drug manufacturing. The letter also flagged the company’s inadequate corrective and preventive measures.
These problems were no longer mentioned in a visit a year later, in March 2023, suggesting that Alvotech had resolved them.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
