Amgen Submits BLA for Adalimumab Biosimilar Despite Patent Battles

Amgen’s ABP 501, a biosimilar competitor to AbbVie’s adalimumab (Humira), has finally been submitted to the FDA for a Biologics License Application (BLA). A tumor necrosis factor alpha blocker, ABP 501 was submitted for review following results from a phase 3 study in 500 patients comparing efficacy and safety of the biologic in patients with moderate to severe plaque psoriasis and rheumatoid arthritis.

In a press release announcing the submission, Amgen said the phase 3 studies proved ABP 501 was clinically equivalent to adalimumab, and was equally safe. The submission also includes a plan for transitioning patients currently on adalimumab to ABP 501.

However, product launch may prove a nightmare for Amgen. According to Reuters, the US patent office recently denied petitions by Amgen to review 2 formulation patents held by AbbVie for Humira. Amgen, however, will continue to pursue the case in court, and expects to launch its product between 2017 and 2019.

AbbVie, meanwhile, expects sales of its blockbuster product to reach $18 billion by 2020, and does not expect biosimilar competition till 2022, due its various patents.

Amgen is facing biosimilar competition for some of its own products. This includes Zarxio, a Sandoz product and the first biosimilar to be approved in the United States. It competes with Amgen’s Neupogen. Sandoz has also filed a BLA for a biosimilar to etanercept (Enbrel), developed to treat autoimmune disease.

While the Biosimilar User Fee Act or BsUFA target action date for ABP 501 is set for September 25, 2016, Amgen continues to focus on developing competitor biologics for Eli Lilly’s Erbitux; Roche’s Avastin, Herceptin, and Rituxan; and Johnson & Johnson’s Remicade.