In November, Amgen submitted its version of AbbVie’s rheumatoid arthritis (RA) biologic Humira to the US Food and Drug Administration (FDA) for review, and yesterday the drugmaker announced the application has been accepted.
The biosimilar ABP 501 was submitted with data showing clinical equivalence, and comparative efficacy and safety to AbbVie’s reference product and the FDA has set a Biosimilar User Fee Act (BsUFA) target action date of September 25 for the molecule.
“If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions,” Amgen’s EVP of R&D Dr Sean Harper said in a statement.
But even if the biosimilar is approved, Amgen may end up unable to launch the product for a number of years as AbbVie says Humira’s US exclusivity will not expire until at least 2022 due to a complex web of manufacturing, formulation and patient-centric patents.
The two firms are embroiled in a legal battle over the extent of Humira’s patent maze, and last week Amgen was dealt a blow after the US Patent Trial and Appeal Board (PTAB) rejected its inter partes review (IPR) challenge over reformulation IP granted to AbbVie in 2014.
Despite the ruling, an IP lawyer told this publication the fight was far from over and “the game is far from over” for Amgen.
AbbVie is set to report its fourth quarter 2015 earnings this Friday, and all ears will be on the performance of Humira outside of the US where it has already begun to see competition from the RA biosimilar Infliximab (a version of J&J’s Remicade), and could suffer from the recent approval of Samsung Bioepis’ Enbrel biosimilar, Benepali.
Guidance on its way
The first US biosimilar launched last September, but there remain questions about the interchangeability of such drugs with their reference products, as well as the naming of copycat biological products.
But in its agenda released this week, the Agency has announced three much awaited guidance documents will be published this year to support biosimilars in the US. They are:
- Considerations in Demonstrating Interchangeability With a Reference Product
- Labeling for Biosimilar Products
- Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity