ABP 501 (adalimumab biosimilar) filed in EU for Moderate-to-Severe Plaque Psoriasis and Moderate-to-Severe Rheumatoid Arthritis- Amgen

Amgen has announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501 (adalimumab biosimilar) in Moderate-to-Severe Plaque Psoriasis and Moderate-to-Severe Rheumatoid Arthritis. Amgen's MAA submission includes analytical, clinical and pharmacokinetic data. Phase III comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab in both studies. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

Comment: Although Humira is set to go off patent in the EU in 2016, AbbVie claims that Humira patents (14 patents) extend for formulation to 2022 and patents (24 patents) for manufacturing to 2027 and for method of treatment to 2022. More than 550 biosimilars are now in development worldwide, and demand is set to surge as a result of patent expiration on major biologics.