Udenyca Biosimilar Drives Growth for Coherus Biosciences

Largely because of the success of its first marketed product, Udenyca, a pegfilgrastim biosimilar referencing Amgen’s Neulasta, biosimilar developer Coherus Biosciences, of Redwood City, California, achieved net income for the first quarter of 2020 of $35.6 million, up from a $20 million loss in the year-ago quarter, the company said in an earnings statement.

Udenyca launched on the US market on January 3, 2019, after being approved for marketing in the European Union in September of 2018.

Coherus has multiple biosimilars under development. CHS-1420, an adalimumab biosimilar, recently completed a phase 3 trial, and Coherus is focused on securing a 2023 launch in the US market when AbbVie’s Humira exclusivity expires.

In January 2020, the company signed an agreement to commercialize Innovent’s bevacizumab biosimilar candidate (IBI305). Largely because of this deal, Coherus’ research and development (R&D) expenses went up 76%, from $18.8 million in the first quarter of 2019 to $33.1 million for the just-ended quarter.

The license to commercialize IBI305 was obtained from Chinese biopharmaceutical company Innovent Biologics. Coherus will market the product, which references Genentech’s Avastin, in the United States and Canada. The agreement required a $5 million upfront payment.

Coherus’ Adalimumab Biosimilar Progress

R&D expense surges were also due to increased costs related to Coherus’ filing preparations for a 351(k) biologics license application (BLA) for their adalimumab biosimilar (CHS-1420) referencing Humira during the second half of 2020, as well as the development of the company’s other biosimilar products.

Coherus saw a roughly 8% increase in selling, general, and administrative expenses during the first quarter as well. These costs were offset slightly by a decrease in legal costs thanks to a patent litigation settlement with AbbVie over adalimumab biosimilars, which occurred in November of 2019. Coherus entered the settlement with Amgen.

Coherus’ Other Biosimilar Developments

In addition to CHS-1420 and IBI305, Coherus has other biosimilar products in development.

CHS-0214, their etanercept biosimilar referencing Amgen’s Enbrel, is currently being tested in a phase 3 clinical trial for patients with psoriasis and rheumatoid arthritis.

CHS-2020, their aflibercept biosimilar, is in preclinical development. This references Regeneron’s Eylea, which is indicated for the treatment of age-related macular degeneration (AMD), macular edema, and diabetic retinopathy. CHS-2020 is expected to enter a phase 3 clinical trial in 2021, with a launch in 2025 if approved.

Coherus has also obtained commercial rights for Bioeq’s biosimilar for Genentech’s Lucentis (ranibizumab), which is undergoing a phase 3 trial for the treatment of wet AMD.

Bioeq is planning for resubmission of a ranibizumab BLA in the second half of 2020 for market launch in the United States.

In January 2020, Coherus gained the commercialization rights for Innovent’s rituximab biosimilar referencing Biogen/Genentech’s Rituxan.

COVID-19’s Effects on Coherus

Although Coherus saw growth during the 2020 first quarter, the coronavirus disease 2019 (COVID-19) pandemic caused slower revenue growth than anticipated, company officials said.

“There are reasons to expect that the adverse effects we are experiencing and expect to continue to experience from COVID-19 in the second quarter and second half of 2020 will be transient and most significant during the period that the COVID-19 pandemic is having its greatest impact on the medical system and personal behaviors,” the company said in its earnings statement.

Coheus also stated that they are experiencing and may experience COVID-related disruptions such as restrictions on company travel and customer access, delays in approvals by regulatory bodies, delays in product development efforts, and “shelter in place” orders that could affect the manufacturing and sales of Udenyca.