Following the news that the European Medicines Agency (EMA) has approved Kixelle, Biocon/Mylan’s biosimilar of Novo Nordisk’s Novolog/NovoRapid (insulin aspart);

Samisha Khangaonkar, Pharma Analyst at GlobalData, offers her view:

“While Key Opinion Leaders (KOLs) interviewed by GlobalData are relatively brand agnostic when prescribing rapid-acting insulin analogs, there is a general hesitancy to prescribe insulins from unfamiliar manufacturers.

“The merger and rebrand of Mylan and UpJohn as Viatris, a division of Pfizer, likely addresses some of the major barriers previously holding back the commercial success of Biocon’s biosimilars, such as marketing capabilities and manufacturing trust. Establishing biosimilar insulin manufacturing trust, coupled with competitive pricing will likely encourage payers to develop biosimilar contracts with Viatris/Pfizer, and with other biosimilar manufacturers over time, such that the out-of-pocket price of insulin will be cheaper for patients and weaken the barrier that pricing can be for overall diabetes health management.

“Biosimilars will have a significant impact on healthcare costs due to its competitive pricing. For example, Biocon/Mylan’s Semglee (biosimilar insulin glargine) has a wholesale acquisition price that is 64% cheaper than its reference product, Sanofi’s Lantus (insulin glargine). Biosimilar uptake is increasing across the EU, as Nationalized Health Systems continue to place a greater emphasis on cost-consciousness. However, biosimilar uptake has been slower in the US due to the existing payer contracts with established insulin developers such as Novo Nordisk, Eli Lilly and Sanofi.

“While Pfizer is not an established player in the insulin space, GlobalData expects that Pfizer will still be able to provide brand recognition in the insulin arena, and provide manufacturing validity to biosimilars launched by Biocon/Viatris by nature of Pfizer’s long history in the overall pharma space.”