Coherus Biosciences thinks it will be able to amp up its Udenyca® sales in 2023, by introducing a competitor on-body injector to Neulasta OnPro®.
According to IQVIA data, Amgen’s Neulasta OnPro currently has about half of the marketshare for the entire pegfilgrastim category. Biosimilars hold approximately 30% of the total uptake, and Coherus’ product is still leading the biosimilar pack. However, in the first quarter of 2022, Coherus registered a 28% drop in net revenue compared with the same quarter last year. This was, according to the company, “primarily due to a decrease in the number of units of Udenyca sold as well as a lower net realized price due to increased competition.” This is unsurprising, based on previous reporting and statements from the company.
Competing with OnPro could unlock greater sales over the long term. Coherus itself believes that this is a $1 billion market opportunity, with little or no competition from the other pegfilgrastim biosimilar manufacturers. Coherus has been working on its on-body injector formulation for some time. In October 2021, the company released the positive results of a pharmacokinetic and pharmacodynamic study of its on-body injector form of Udenyca versus its original prefilled syringe. This phase 1 study likely formed the basis of its “prior approval supplement” to the Udenyca biologic licensing application (BLA), which is awaiting approval with the Food and Drug Administration (FDA). The company is expecting to be able to launch this delivery form in 2023.
Assuming it is successful in its endeavor, this will be the first time a biosimilar will be introduced in two very different delivery forms. Celltrion has marketed in other countries, and is seeking approval from the FDA, a subcutaneous formulation of infliximab (sold in the US as Inflectra®), in addition to the conventional infusible form. However, the reference product (Remicade®) was not available in an injectable form, so the FDA must consider Celltrion’s new product approval as somewhat different from a standard 351(k) application or prior approval supplement to a biosimilar BLA. Instead, FDA required Celltrion to submit its subcutaneous form as a new drug or “bio-better.” This meant new phase 3 trials, the last of which will have initial results in July 2022. Based on this date, an FDA decision may be possible in 2023. Of further interest, the phase 3 trials involve patients with Crohn’s disease and ulcerative colitis. Based on these results, will the FDA grant Celltrion extrapolation to the other indications of Inflectra’s infusible form, like it can do for other biosimilars?
Fortunately for Coherus, no phase 3 trials are needed for its investigational on-body injector. Both Neulasta and OnPro have been proven to offer equivalent clinical efficacy, as well as pharmacologic properties. The only questions are when the launch will occur, and how quickly Coherus can erode OnPro’s marketshare.
In related biosimilar news…Coherus Biosciences also announced that it was discontinuing development of its bevacizumab biosimilar candidate CHS-305, which the company said was delayed due to COVID. This marks the end of a partnership with Innovent Biologics, which was initially announced in January 2020. Coherus also decided to drop the development of its aflibercept biosimilar, with partner Junshi Biosciences. Junshi continues to work with Coherus on other investigational biologics.