During the Coherus Biosciences earnings call, the company announced that it was terminating its licensing agreement with Innovent Biologics for Byvasda, a bevacizumab biosimilar candidate referencing Avastin.
In Coherus Biosciences' earnings conference call for the first quarter (Q1) of 2022, the company announced it has discontinued development of a bevacizumab biosimilar candidate (CHS-305; IBI-305; Byvasda).
Coherus entered into a license agreement with Innovent Biologics for the candidate in January 2020. Under the partnership, Coherus was to have the development and commercialization rights of CHS-305 in any dosage form and presentation in the United States and Canada, according to the company’s 2021 annual report. Coherus will be returning the rights to Innovent Biologics.
During the call, McDavid Stilwell, chief financial officer at Coherus, attributed the end of the partnership to the COVID-19 pandemic, saying that it “commenced shortly after execution of this agreement, and has caused significant delays to the development timeline."
He continued, "We have recently assessed the market dynamics and given ongoing and projected COVID-related delays, we determined that this program no longer warrants for continued investment.”
Byvasda was approved by China’s National Medical Products Administration (NMPA) for use in patients with lung and colorectal cancers in June 2020. In June 2021, the NMPA expanded the indication list for the biosimilar to include unresectable hepatocellular carcinoma when combined with sintilimab therapy.
Coherus also dissolved its partnership with Junshi Biosciences over a biosimilar referencing Eylea (aflibercept), for which it paid Junshi $11.5 million in costs related to the discontinuation during the first 3 months of 2022.
More Biosimilar Updates
In a press release regarding the earnings call, Coherus reported that net sales of Udenyca (pegfilgrastim-cbqv), a biosimilar for Neulasta, reached $60.1 million during Q1 of 2022, a 27.6% decline from the same quarter in 2021 ($83.0 million). The Redwood City, California-based company said the decline was primarily caused by a decreased number of units of the product sold and a lower net realized price due to increased competition in the pegfilgrastim space.
In the United States, Udenyca is competing against 3 other pegfilgrastim biosimilars along with the reference product, which is offered for delivery intravenously or with an on-body injector. In the European Union, there are 8 pegfilgrastim biosimilars including Udenyca.
Coherus also noted the FDA review of the biologics license application for its ranubizumab-ranq (Cimerli), a biosimilar referencing Lucentis, is expected to be completed by August 2, 2022. Currently, the United States and European Union have approved 1 ranibizumab biosimilar for marketing (Byooviz). However, it is not expected to enter the US market prior to June 2022.
Selling, general, and administrative expenses for the quarter amounted to $48.8 million compared with $39.4 million during Q1 2021. Coherus attributed the increase to higher commercialization expenses related to Udenyca sales and preparation for the product launches anticipated for 2022 and 2023, including Cimerli, the on-body injector presentation of Undenyca, and Yusimry (adalimumab-aqvh), the company’s biosimilar referencing Humira.
Yusimry received FDA approval in December 2021 and is anticipated to launch on or after July 2, 2023, around the same time as several other adalimumab biosimilars.