2015 will be remembered as the year biosimilar competition hit the US, with Sandoz taking aim at Amgen’s Neupogen (filgastrim) by launching the first copycat product on to the market in September.
Since then there has been a flurry of activity, with the US Food and Drug Administration (FDA) accepting versions of Enbrel (etanercept) and Neulasta (pegfilgrastim) for review, both top selling Amgen products.
But this week Amgen has shown it too is looking to take a slice of the US biosimilar market - estimated to be worth $11bn (€10.4bn) by 2020 - submitting a Biologics License Application (BLA) to the FDA for ABP 501, a version of AbbVie’s Humira (adalimumab).
Developed through the biosimilar-specific 351(k) pathway, the US submission is both the first by Amgen and the first, the company believes, for a version of the anti-inflammatory mAb which achieved revenues of $6.5bn in the US in 2014.
Patent maze
The submission was described as “an exciting milestone,” by Amgen’s EVP of R&D Sean Harper, but AbbVie spokesperson Alissa Bolton told Biopharma-Reporter any biosimilar maker will have a tough time developing and launching a copycat of Humira.
“Humira is one of the most comprehensively studied biologics available, has a well-established safety profile and is a trusted treatment that is supported by 12 years of physician and patient experience post-approval,” she said.
“Biosimilars will need to address AbbVie’s robust patent portfolio including manufacturing patents, formulation patents, and patents that cover the indications for which Humira is currently approved.
“In the United States, these patents expire no earlier than 2022, and we will vigorously enforce these patents,” she continued, reiterating her CEO’s comments during AbbVie’s last financial call.
“The vast majority of these patents, which reflect significant innovation and investment, were granted by the US patent and trademark office within the past two years,” he said. “The size of AbbVie's patent estate is a direct consequence of the ground-breaking work of AbbVie scientists in a new field of biologics.”
Humira biosimilars
While Amgen’s submission is believed to be the first in the US for adalimumab, there are a number of other developers targeting AbbVie’s reference product.
Boehringer Ingelheim recently announced it has completed enrolment for a Phase III trial for BI695501, its version of the blockbuster biologic. Meanwhile Baxalta, in a partnership with Momenta Pharmaceuticals, has initiated a pivotal clinical study for its biosimilar M923 and is aiming for its first regulatory submission in 2017.
Other developers include Samsung Bioepis and Oncobiologics, while last December Zydus Cadila launched the first biosimilar competitor to Humira on the Indian market.