Currently, Amgen’s Neulasta OnPro® holds approximately half the marketshare for the pegfilgrastim category. This on-body injector (OBI) system is deemed more convenient than the conventional prefilled syringe, as patients are not required to travel to the office or clinic for pegfilgrastim administration the day after receiving chemotherapy.
This month, Coherus Biosciences announced that its phase 1 trial of its own OBI system for Udenyca® has yielded positive results. This is an important step for Coherus; while Udenyca is the market-leading biosimilar, its share of the category has not grown in several quarters. The development of a proprietary OBI may be the key to unlocking additional marketshare from Amgen.
In its press release, Coherus stated that the open-label, crossover study compared pharmacokinetic and pharmacodynamic bioequivalence of the OBI-delivered agent with Udenyca’s prefilled syringe. The study comprised 189 healthy subjects who were randomized to receive one to two cycles of Udenyca delivered via OBI and then the prefilled syringe, or the reverse. The study did not reveal any meaningful differences between the two formulations or in differences in the absolute neutrophil count. Furthermore, the study did not reveal any new safety signals.
The next step for Coherus is to obtain FDA approval. Udenyca OBI is not technically considered a biosimilar of Neulasta OnPro, thus a new 351(k) application is not required. Coherus will instead submit a “a prior approval supplement to the Udenyca 351(k)BLA,” according to the company. This seems to be a first, publicly announced in any case.
We presume the pathway may be similar to an abbreviated pathway for pharmaceuticals approved under the Food Drug & Cosmetics Act seeking new dosage forms. Coherus says that it will seek marketing authorization in 2022 and that the process should take 10 months, which could potentially result in approval by the end of that year.
Another Formulation of a Biosimilar and a Different Path
In an interesting comparison, consider Celltrion’s path to FDA approval for its subcutaneous injectable form of the infliximab biosimilar Inflectra®. Its phase 3 study in Crohn’s disease will yield preliminary results in August 2022. This study is not comparing the outcomes of the infusible form of Inflectra with the investigational SC form, or with the reference product Remicade®—rather, the comparator is a placebo subcutaneous injection. Remicade is only available in an infusible form, given at a doctor’s office or clinic. Celltrion is preparing a placebo-controlled, randomized study in preparation for filing a new 351(a) licensing application. If approved (and it already is marketed in Europe and Canada), this new administrative formulation will not technically be considered a biosimilar.