The FDA has accepted biologics license applications (BLAs) for interchangeability status from Alvotech and Pfizer regarding their respective adalimumab biosimilars referencing Humira.
The FDA has accepted for review a biologics license application (BLA) supporting interchangeability for Alvotech’s high-concentration, citrate-free formulation of its adalimumab biosimilar referencing Humira (AVT02; 100 mg/ml).
According to the company, the FDA has set a goal decision date of December 2022. Biosimilars for Humira will be able to enter the US market in January 2023.
“We believe the potential combination of interchangeability with our high-concentration strength of AVT02 reflects a proactive approach to biosimilar development as well as our commitment to patients,” said Robert Wessman, founder and chairman of Alvotech.
The BLA contains data supporting interchangeability between AVT02 and Humira collected from a randomized study that demonstrated bioequivalence of repeated switches between the reference product and the biosimilar compared with administration of the reference product without switching.
Alvotech is the only known company that has developed a high-concentration biosimilar candidate to compete against Humira and conducted a switching study to support initial approval as an interchangeable biosimilar at the same time.
More on AVT02
Previously, in September 2021, the FDA said that its review of the BLA would be deferred due to the COVID-19 pandemic, which interrupted travel for inspections for manufacturing facilities. Around the same time, Alvotech announced positive results from its switching study, finding that switching from the reference product to the biosimilar produced no significant differences in clinical efficacy, safety, or immunogenicity compared with the cohort group that was solely treated with Humira.
Although high-concentration and low-concentration versions of the reference product are available on the US market, over 80% of Humira prescriptions are for the high-concentration formulation. According to Alvotech, sales of Humira topped $20.7 billion in 2021, solidifying the drug as the highest grossing pharmaceutical product globally that was not a vaccine for COVID-19.
Alcotech has a commercialization agreement with Teva Pharmaceuticals for the marketing of AVT02 in the United States once it is approved. AVT02 was granted marketing authorization in the European Union in January 2022, where it will be marketed by STADA Arzneimittel under the names Libmyris and Hukyndra depending on the country.
Also in January 2022, Alvotech received approval for the Canadian market for AVT02, where it will be marketed as Simlandi. The Canadian launch will be managed by JAMP Pharma Group, a Canadian company based in Montreal.
Potential for 5 Interchangeable Adalimumab Biosimilars
As the United States approaches the 2023 launch of potentially 8 adalimumab biosimilars, including the 7 FDA-approved products and AVT02, companies are racing to obtain interchangeability designations.
Currently, only 1 adalimumab biosimilar has an interchangeability designation: Boehringer Ingelheim’s Cyltezo. Cyltezo marked the nation’s second biosimilar to ever receive the designation, following the approval for Semglee, an insulin glargine biosimilar developed by Biocon Biologics.
Just a few days before Alvotech’s announcement, Pfizer also announced that the FDA had accepted its application for interchangeability for Abrilada, the company’s low-concentration adalimumab biosimilar. The FDA is expected to give its decision on Abrilada in the fourth quarter of 2022. The FDA originally approved Abrilada in November 2019 and the drug is expected to enter the market in November 2023.
“An interchangeability designation for Abrilada would help to support increased use of biosimilars by pharmacists and potentially lead to further cost savings,” said Mike Gladstone, global president of inflammation and immunology at Pfizer, in a statement.
In November 2021, Amgen said that its seeking interchangeability status for its low-concentration adalimumab biosimilar (Amjevita). Amjevita was approved by the FDA in September 2016 and is expected to be the first adalimumab biosimilar to launch in the United States in January 2023.
In January 2022, Samsung Bioepis and Organon announced that they are seeking interchangeability for a high-concentration, citrate-free version of their adalimumab biosimilar (Hadlima), which was approved as a low-concentration formulation in July 2019 and is expected to launch on the US market in June 2023.