The US Food and Drug Administration (FDA) has said that an Amgen biosimilar is indeed “highly similar” to AbbVie’s drug Humira (adalimumab) in a document released for the advisory committee panel meeting due to be held tomorrow.
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With unanimous backing of its expert panel, the US FDA now looks nearly certain to approve Amgen’s (NASDAQ:AMGN) Humira biosimilar, ABP 501, across all indications by late September.
On Tuesday the panel unanimously recommended approval for Amgen’s biosimilar version of AbbVie Inc’s arthritis drug Humira. The US biotech sued Sandoz in March, claiming that GP2015 infringes its US patents and is seeking an injunction on sales even if the FDA approves it. If approved, Amgen’s drug would join a new wave of so-called biosimilars, which have the potential to generate billions in savings for USA insurers, doctors and patients. Although the issue will take years to resolve, Height Securities analysts believe if these patents are invalidated in the next couple of months, “a favorable ruling will likely pave the way for Coherus to enter the market much sooner than 2022”.
If the drug is approved, Amgen plans to launch ABP 501 by 2018.
Sandoz’ drug is also being reviewed in Europe where the first biosimilar version of Enbrel, made by Samsung Bioepis, was approved in January. It accounted for 60% of AbbVie’s total revenue previous year. The injectable drug, which blocks chemicals linked to inflammation, is approved for multiple uses, including rheumatoid arthritis, Crohn’s disease and psoriasis. In documents posted on the agency’s website July 8, the FDA said ABP 501 effectively replicates Humira’s treatment of rheumatoid arthritis and the other conditions it treats.
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Patient groups urged the FDA to finalize rules for how biosimilars should be named and labeled and for rules to be put in place ot prevent insurance companies from switching patients from a drug that they know works to one they don’t know. Nonetheless, biosimilars are priced lower than their branded counterparts; a year ago biologic drugs made up six of the world’s top 10 bestselling medicines, pulling in combined sales of over $56 billion.
