Amjevita will be offered in a citrate-free formulation to reduce pain at the injection site and will be commercialised in a prefilled syringe and autoinjector presentations to support dosing in each of the approved indications
Amgen headquarters in Thousand Oaks, California. (Credit: Coolcaesar/Wikipedia)
US-based biotechnology company Amgen has announced the US commercialisation of Amjevita (adalimumab-atto), its biosimilar to AbbVie’s antibody therapy Humira (adalimumab).
Amjevita’s active pharmaceutical ingredient (API) is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as Humira.
Amgen is offering the drug in a citrate-free formulation, just like Humira, to help reduce pain at the injection site.
Amjevita will be commercialised in a prefilled syringe and autoinjector presentations to support dosing in each of the approved indications, said the company.
Amgen global commercial operations executive vice president Murdo Gordon said: “With today’s announcement, Amjevita is the first US biosimilar to Humira, a medicine used by more than a million patients living with certain serious inflammatory diseases.
“With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply this biosimilar medicine while reducing costs.”
Amjevita was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA) in 2016 to treat seven inflammatory diseases.
The diseases include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, and ulcerative colitis.
Amgen claimed that it is offering Amjevita (40mg) at a list price 55% lower than the current list price of Humira to provide broad access to patients.
Amjevita is marketed as Amgevita (adalimumab) outside the US and has been prescribed to more than 300,000 patients in over 60 countries.
Furthermore, the company is providing patient support, such as financial support information and educational resources, through the Amjevita SupportPlus initiative.
Arthritis Foundation president and chief executive officer Steven Taylor said: “Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the healthcare system. Amjevita provides another treatment option for patients and their doctors.”
In December last year, Amgen agreed to acquire Irish biopharmaceutical company Horizon Therapeutics in an all-cash transaction valued at $27.8bn.