Coherus has announced that its proposed adalimumab (Humira) biosimilar met the primary endpoints in a bioequivalence study, which signifies an important step towards approval.
The drug, currently referred to as CHS-1420, achieved the necessary criteria for clinical pharmacokinetic (PK) similarity to the reference drug in a randomized, double-blind study. It assessed bioavailability after administration of a 40 mg injection using 3 metrics: 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.
This early-stage study, conducted in healthy subjects, also found that CHS-1420 was well-tolerated and did not find any safety differences between the biosimilar and the branded drug. In the announcement, Coherus executives expressed optimism about the study findings and the future of the potential biosimilar.
“Positive results from this study are an essential global regulatory requirement to demonstrate PK bioequivalence on multiple prespecified primary PK endpoints between CHS-1420 and Humira,” said Barbara Finck, MD, chief medical officer of Coherus. “We are pleased to have achieved results which we believe represent a significant reduction in development program risk.”
“This is our second successful CHS-1420 PK study,” added Denny Lanfear, president and CEO of Coherus. “Our ability to achieve these results gives us confidence that we can similarly complete future PK studies with modified formulations, anticipated to commence later in 2017.”
Coherus has 2 other biosimilar products under development, for etanercept (Enbrel) and pegfilgrastim (Neulasta). The company has already filed a Biologics Licens Application in the United States and Europe for the pegfilgrastim biosimilar, while the etanercept biosimilar is in phase 3 studies.
Adalimumab is used to treat autoimmune diseases like rheumatoid arthritis, Crohn’s disease, and some kinds of psoriasis. Since the patent on Humira expired in 2016, the FDA has approved 1 adalimumab biosimilar, Amjevita, made by Amgen. Its entrance into the market has been delayed by patent lawsuits brought by AbbVie, which manufactures Humira.
Coherus is not the only drug maker jumping into the fray of adalimumab biosimilars. Sandoz, a subsidiary of Novartis, has been developing its own candidate, but delayed filing its planned application with the FDA. Executives said that the delay was unrelated to the drug’s clinical performance; instead, the application was postponed so the company could have time to upgrade its manufacturing facilities before an inspection would be required.