A quick update here before the company announces full-year 2022 operating results and gives the latest glimpse into its roadmap for 2023 and beyond.

Coherus BioSciences this morning announced the U.S. Food and Drug Administration (FDA) approved an autoinjector device for Udenyca, its pegfilgrastim product. This not the on-body injector device that would blow up my modeling (in a good way). To be honest, I didn't even know the company was working on an autoinjector device!

This now means the company is building a portfolio of Udenyca (pegfilgrastim) formulations and devices in a long-term strategy to capture market share:

• Udenyca PFS is the pre-filled syringe formulation. This is the standard formulation for patients in a doctor office, but it requires relatively frequent trips into the office.
• Udenyca AI is the autoinjector formulation. This can be administered in a doctor office or at home, which offers a bit more flexibility than PFS products.
• Udenyca OBI is the on-body injector formulation. Half of the pegfilgrastim market is off limits to biosimilars because there's only one OBI formulation available -- Neulasta Onpro -- and it rakes in about $1 billion in annual revenue.

This out-of-left-field development is not factored into any of our models for Coherus BioSciences. It could make a meaningful change to the company's growth trajectory. A few quick thoughts I'm kicking around with the news fresh off the presses:

• The company has sacrificed market share for Udenyca PFS in the last 12 months by not lowering prices as quickly as the competitive landscape. It has always maintained that future formulations would position the business to grow market share again. That strategy certainly makes more sense with three formulations (PFS, AI, OBI) in the portfolio.
• This is the first AI formulation available for any pegfilgrastim product -- not even Neulasta from Amgen has one. However, that could be a sign Amgen decided an AI formulation didn't add enough value in this treatment setting.
• The PFS and OBI formulations cover all treatment settings, from the doctor office to at-home care, whereas the AI formulation exists in between. Is a moderate amount of flexibility valuable enough to make the product succeed?
• On the one hand, an AI formulation may only be a niche product for individuals that live sorta-kinda close to a treatment facility, but not for those living close or far away. On the other hand, doctors may use Udenyca AI as an intermediate for patients currently taking a PFS product and/or before trying Neulasta Onpro (changing prescription behavior is difficult though).
• Will doctors balk at the new offering if the company doesn't have equivalency data comparing the AI formulation to PFS formulations?
• The AI formulation allows Coherus BioSciences to avoid a legal challenge from Amgen. This is the first such formulation in the pegfilgrastim market, so Amgen cannot sue to protect its not-existent product.

This is an entirely new product with no comparison in the pegfilgrastim market. Possible outcomes include acting as a saving grace for the Udenyca franchise to building a bridge to a delayed Udenyca OBI launch to being a complete dud. I'll need some time to model its contributions, but let's see what management says about the AI formulation on the call later today.

Further Reading

• March 2023 press release announcing FDA approval of autoinjector device for Udenyca AI

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