Coherus BioSciences Wins Another FDA Approval
Taking a Look at Coherus BioSciences' (CHRS) Approval for Udencya OBI, Weekly Activity, & Portfolio Update.
This past week, although brief, marked a relatively neutral period for the market and my portfolio. With the earnings season at a close, it's an excellent time to dive into significant news and updates from the companies within my coverage area. A notable highlight of the week was the announcement from Coherus BioSciences (CHRS) regarding their Udenyca franchise. This development presents an important turning point for CHRS, and I aim to unpack the details and implications of this news. Let’s explore what this means for the company moving forward.
Please reference my most recent articles in the archive on CHRS for in-depth information on the business.
Udencya OBI is Now Approved
CHRS announced the FDA approval of Udencya OBI (On-Body Injector), which is aimed at reducing infection risks in cancer patients post-chemotherapy. This new product, a pegfilgrastim biosimilar, helps decrease febrile neutropenia incidence, a common infection-related complication in patients undergoing myelosuppressive anti-cancer treatments. The Udencya OBI device, distinct in its design and function, offers an automatic medication delivery option. Key features include a fast five-minute injection time, an intuitive retractable needle mechanism to minimize needlestick injury risks, and a patient-friendly design with visual and audible indicators ensuring correct dosage delivery. The device's approval was backed by extensive clinical data, including pharmacokinetic and pharmacodynamic bioequivalence studies.
Their Udencya franchise, which has been available since 2019, now offers three administration methods: prefilled syringe (PFS), autoinjector (AI), and the newly approved OBI. Over 300,000 patients have been treated with Udencya, which is also indicated for increasing survival in patients exposed to myelosuppressive radiation doses. The commercial launch of Udencya OBI is expected in the first quarter of 2024.
Market Dynamics and Udenyca OBI's Entry
In the pegfilgrastim market, where nine unique products exist, Amgen's Neulasta Onpro is the only on-body injector (OBI) formulation, commanding a nearly 40% market share by the end of 2023. This dominance is partly due to a lack of direct competition and Amgen's extensive patent holdings in this area. The OBI units, like Neulasta Onpro, provide pegfilgrastim doses automatically a day after chemotherapy, which is more practical for many patients.
In 2022, nearly 1.3 million pegfilgrastim units were sold, with a significant market split between PFS and OBI units. CHRS' Udenyca OBI directly competes with Neulasta Onpro for a substantial portion of the market. CHRS also leads with its PFS product (Udenyca) and offers an autoinjector (AI) formulation (Udenyca AI) for those preferring a non-wearable option. These products collectively position CHRS to capture significant market share in 2024.
Investors should note that while CHRS' strategy is ambitious, it faces substantial patent challenges, particularly from Amgen's extensive patent portfolio. CHRS might navigate these legal hurdles, yet the uncertainty complicates revenue projections. Some predict in early 2025, some are predicting in early 2024.
Despite potential legal battles, CHRS asserts that Udenyca OBI is unique, particularly in its rapid administration time compared to Neulasta Onpro. This difference could be a pivotal factor in its market success. CHRS' entry into the OBI market with Udenyca OBI is a significant development, offering potential benefits for patients. However, investors should remain aware of the legal complexities and competitive dynamics that could influence the product's success in the market.
Weekly Activity (December 26th-29th)
Nothing.