Coherus Announces Positive Topline Results for CHS-1420 Days After BI Receives Approval for Cyltezo

Coherus BioSciences today announced positive topline results for the first of 3 pharmacokinetic bioequivalence studies comparing CHS-1420, an adalimumab biosimilar candidate, and European-sourced reference Humira.

The California-based biosimilar developer said that the study (a randomized, single-blind, single-dose, parallel-group study in 216 healthy subjects) met its 3 primary endpoints: maximum serum concentration, area under the time-concentration curve from first to last time point measured, and area under the time-concentration curve from first time point extrapolated to infinity. The 90% confidence intervals of the geometric mean ratios for all PK endpoints fell within predefined bioequivalence boundaries of 80% to 125%.

News of Coherus’ results comes just days after the FDA approved another adalimumab biosimilar, Boehringer Ingelheim’s (BI) Cyltezo, for multiple indications. BI is also currently investigating interchangeability between its product and Humira.

However, while AbbVie faces mounting competition for its top-selling treatment, it is unlikely that the drug maker will see immediate erosion of its sales in the US marketplace; earlier this month, AbbVie filed suit against BI, claiming that the biosimilar developer will infringe on 74 of its patents covering Humira. With only 8 of those patents currently being litigated, the case could take a substantial period of time and investment of resources to resolve.

Likewise, the first US-approved adalimumab biosimilar, Amgen’s Amjevita, is still awaiting its launch after receiving the FDA’s approval in September of 2016. Litigation in AbbVie v Amgen is ongoing, with the case recently reassigned to a visiting judge in the Eastern District of Pennsylvania.

AbbVie faces a harder fight to protect its Humira sales in the international marketplace, however. In Australia, a federal court recently ruled that AbbVie cannot file for an extension of 3 of its patents on Humira because they protect methods of use rather than the drug itself.

Meanwhile, Samsung Bioepis’ own adalimumab biosimilar, Imraldi, was approved in the European Union last week after having received a previous positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in June of 2017.