Amjevita was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016, with its launch delayed until now due to a settlement with AbbVie.
The world’s best-selling drug, Humira has not faced competition in the US prior to this launch, with it generating sales of over US$20bn last year.
Amgen said the biosimilar will have two list prices, which represent a discount of either 5% or 55% to Humira. It explained that as its goal is to provide broad access for patients, it is offering two options to health plans and pharmacy benefit managers.
The active ingredient of Amjevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as Humira. The Amgen biosimilar product is available in prefilled syringe and autoinjector formats and is approved to treat seven inflammatory diseases. Outside the US, the drug is marketed as Amgevita (adalimumab); it has been prescribed to more than 300,000 patients in over 60 countries.
Reacting to the launch, Juliana M Reed, executive director of the Biosimilars Forum, said this is a watershed year for biosimilars in the US, with at least seven FDA-approved Humira biosimilars set to enter the market, boost competition, and drastically reduce prescription drug costs.
“The cost-savings of biosimilars can only be realized if all biosimilars, especially biosimilars for Humira, are fully available and accessible to the patients who need them. Biosimilars have the potential to save billions of dollars in US health care spending, if and only if they have equitable access to formularies, allowing free-market competition to lower prescription drug costs.
“The Biosimilars Forum calls on the Biden Administration, Congress, and federal regulators to ensure that Humira biosimilars are available to all Medicare patients. Medicare could have saved an estimated $2.19bn on Humira over four years had biosimilar competition been available.
“Pharmacy Benefit Managers (PBMs) must prioritize patients over profits and place Humira biosimilars on all commercial formularies. This includes midyear formulary access, meaning that all biosimilars become immediately available once launched.”
See Fish & Richardson principals' recent review of US biosimilar market developments in 2022.