- Amgen has filed for FDA approval of ABP501, a biosimilar version of AbbVie's Humira (adalimumab), for treatment of both rheumatoid arthritis and plaque psoriasis. This sets up one of the most hotly-anticipated showdowns of 2016 taking on the best-selling drug in the world.
- As part of its application, Amgen submitted clinical equivalence data, as well as data showing comparable safety and the ability to safely switch between Humira and ABP501.
- Many other companies are also working towards developing a biosimilar for Humira, including Baxalta & Momenta (planning to file in 2017), Merck & Samsung Bioepsis, and Novartis.
With almost $13 billion in sales, Humira is a prime target for companies looking to compete in the emerging U.S. biosimilars market. Amgen submitted a solid application backed by 24-week, phase 3 data showing comparable ACR20 response between ABP501 and Humira. Notably, Amgen, already a biologics powerhouse, is seeking two indications. Humira has two additional indications for psoriatic arthritis and ankylosing spondylitis, which other developers may choose to pursue in their biosimilar versions.
At the same time, AbbVie is shoring up its IP defense team as it prepares to protect its Humira patents, hoping to maintain exclusivity for as long as possible.
It's too early to know pricing plans since Amgen just filed. However, using Novartis' Zarxio (filgrastim-sndz) as a benchmark, the discount may be relatively modest. Zarxio was priced 15% below the branded Neupogen before any discounts and rebates. With this application, there is a good possibility Amgen will be the second company to score a biosimilar victory in the U.S.