First biosimilar to HUMIRA® available in US

AMJEVITA™, the first biosimilar to Humira® is now available in the US, based on four years of real-world experience in over 300,000 patients.

AMJEVITA First biosimilar to HUMIRA® available in US

AMJEVITA™ (adalimumab-atto), a biosimilar to Humira® (adalimumab), is now available in the US.  Amgen’s AMJEVITA was the first biosimilar to Humira approved by the US Food and Drug Administration (FDA), in 2016.

The active ingredient in the anti-TNF-α monoclonal antibody has the same amino acid sequence as Humira. The Humira biosimilar will be available in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications.

Like Humira’s citrate-free formulation that is associated with less pain at the injection site, AMJEVITA is citrate-free.

“Biosimilars are FDA-approved treatments that have the potential to reduce costs to the healthcare system,” explained Steven Taylor, President and Chief Executive Officer at the Arthritis Foundation. “AMJEVITA provides another treatment option for patients and their doctors.”

AMJEVITA, 40mg is available at a list price 55 percent below the current Humira list price. It is also available at a list price 5 percent below the current Humira list price.

Vinie Varkey, Managing Analyst for Immunology at GlobalData shared how the availability of AMJEVITA could affect the US biosimilar market: “Currently, Boehringer Ingelheim’s Cyltezon is the only adalimumab biosimilar that has received interchangeability designation….

“… how quickly adalimumab biosimilars can capture patient share from the originator biologic… [is a] market dynamic that will likely intensify if more adalimumab biosimilars receive interchangeability designation…”

Murdo Gordon, Executive Vice President of Global Commercial Operations at Amgen commented on AMJEVITA’s importance for patients: “AMJEVITA is … used by more than a million patients living with certain serious inflammatory diseases.”

AMJEVITA – biosimilar to Humira

The monoclonal antibody is approved to treat seven inflammatory diseases including:

  • Moderate-to-severe rheumatoid arthritis (RA) in adults
  • Moderate-to-severe polyarticular juvenile idiopathic arthritis in patients two years of age and older
  • Psoriatic arthritis in adults, ankylosing spondylitis in adults
  • Moderate-to-severe chronic plaque psoriasis in adults
  • Moderate-to-severe Crohn’s disease in adults and paediatric patients six years of age and older
  • Moderate-to-severe ulcerative colitis (UC) in adults.

Amgen currently has 11 biosimilar medicines in market or under development. Five are FDA-approved in the US and three are approved in the European Union (EU).

Varkey concluded: “… the launch of AMJEVITA positions Amgen as a key player in the US biosimilar space.”