Coherus Files Adalimumab BLA, Although Intended Concentration Is Unclear

Coherus BioSciences reported that the FDA has accepted for review its biologics license application (BLA) for an adalimumab biosimilar (CHS-1420). The formulation concentration Coherus is seeking was not specified, although the market is swiftly moving away from lower-concentration forms of this agent.

In 2017, the Redwood City, California, company reported topline results from ongoing pharmacokinetic (PK) bioequivalence studies that compared CHS-1420 with a European-marketed version of the reference product (Humira). The company reported that the comparison was based on administration of a 40-mg dose in a group of 216 healthy patients, a trial that met all end points for clinical PK and pharmacodynamic biosimilarity.

By comparison in November, Icelandic company Alvotech indicated that the FDA had accepted its application for a 100-mg/mL dose biosimilar (AVT02). However, Alvotech’s supporting data for the application involved a phase 1 PK similarity study that employed a 40-mg single dose of Humira in healthy subjects and a phase 3 safety and efficacy study that employed an initial loading dose of 80 mg followed by 40 mg every 2 weeks.

In 2016, Coherus reported results from a phase 3 psoriasis study of CHS-1420 that were also positive, demonstrating biosimilarity in patients who achieved a 75% improvement in psoriasis area and severity index measures at week 12. Coherus said CHS-1420 and Humira were “similarly well tolerated with similar safety profiles.” This phase 3 study was intended to support a 351(k) BLA filing in 2017, although that filing was delayed; the company had hoped to achieve a filing by the end of 2020, according to its third-quarter 2020 earnings statement.

Coherus said in its most recent statement that it intends to launch its adalimumab biosimilar in the United States on or after July 1, 2023, under terms agreed upon with AbbVie.

“We are pleased to see the CHS-1420 BLA accepted for review, as we continue to execute on our mission to increase patient access to important medicines and deliver substantial savings to the health care system,” said Denny Lanfear, CEO of Coherus. The company said it anticipates that the US market for adalimumab will be worth $18 billion annually by 2023, representing “substantial pent-up demand” for biosimilar products.

If Coherus brings a low-concentration form of adalimumab to market in 2023, the market may still exist for this version of the blockbuster medication, as competitive pricing may in some cases overcome any disposition on the part of physicians to prefer the higher concentration formulation.