Amgen recently launched Amgevita, a biosimilar to Abbvie’s Humira (adalimumab), in Europe after approval by the European Commission. The therapy will be available in the 28 countries of the European Union, plus Norway, Iceland, and Liechtenstein.
A biosimilar is a biopharmaceutical therapy designed to have active properties similar to a reference product previously approved and licensed (in this case, Humira). As Humira, Amgevita is a human antibody designed to target the human tumor necrosis factor alpha (TNFα) — an immune factor that regulates the inflammatory response.
Amgevita is indicated for the treatment of several pediatric inflammatory diseases, including polyarticular juvenile idiopathic arthritis (in patients age 2 and up), moderate to severe Crohn’s disease, severe chronic plaque psoriasis, and enthesitis-related arthritis.
Additionally, Amgevita is indicated for a range of adult inflammatory diseases, including different types of arthritis, ankylosing spondylitis, and psoriasis.
“The launch of Amgevita in Europe is an important milestone for our biosimilars portfolio, expanding the range of treatment options for the millions of patients living with chronic inflammatory diseases,” David M. Reese, MD, executive vice president of research and development at Amgen, said in a press release.
“Amgevita is Amgen’s second biosimilar to launch in Europe, demonstrating our commitment to providing patients with serious illnesses access to high-quality biological therapies,” Reese said.
The European Commission granted approval to Amgevita based on data supporting its biosimilarity to adalimumab. The data encompassed results from analytical, pharmacokinetic, and clinical studies.
In particular, results from two Phase 3 studies (NCT01970488, NCT01970475) conducted in patients with moderate to severe plaque psoriasis and moderate to severe rheumatoid arthritis showed that Amgevita demonstrated no clinically meaningful differences compared to Humira.
Furthermore, the safety results in patients given Amgevita were comparable to those given Humira.
Amgevita was further assessed in a long-term Phase 3 study (NCT02114931) in moderate-to-severe rheumatoid arthritis patients, which showed that the efficacy of the biosimilar was sustained with no new issues regarding safety or adverse events.
“Building on our strong inflammatory disease presence in the United States, we are excited to develop our inflammation capabilities in Europe,” said Scott Foraker, vice president and general manager of biosimilars at Amgen.
“As the first inflammation biosimilar from our portfolio to launch in Europe, Amgevita will extend our reach and help more patients gain access to this important class of therapies,” Foraker said.
Amgevita will be made available as a prefilled syringe and pre-filled pen (SureClick autoinjector) in order to provide the appropriate dose for the different diseases. Amgevita is not approved for patients younger than 2, as Humira has not been studied in patients of that age.