How will Semglee interchangeable insulin affect access and affordability?

The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar by the US Food and Drug Administration will be a test of whether such designations can make a difference in patient access, Jeff Baldetti of Cardinal Health explains.

Six years after the first biosimilar launched in the USA, at long last we have an interchangeable biosimilar available. The first interchangeability designation was granted to Biocon Biologics, part of Indian firm Biocon (BSE: 532523) and USA-based Viatris’ (Nasdaq: VTRS) Semglee (insulin glargine-yfgn) last month, referencing the long-acting insulin Lantus from Sanofi (Euronext: SAN), which may allow pharmacists to substitute the biosimilar at the counter without consulting the prescribing physician, per state laws. Although the concept of interchangeability may not seem like a ground-breaking idea, the ability to substitute Semglee at the pharmacy could enable faster uptake and broader adoption of retail biosimilars in the USA.

The introduction of the interchangeability designation could unlock lower health care costs and improve access for patients nationwide by providing competition against some of the costliest and most widely used biologic treatments available on the market: insulin products. However, the success of these products will be contingent on several factors including awareness and comfort among providers and patients, pricing strategies that create meaningful discounts for patients, payer and pharmacy benefit manager (PBM) formulary policies, and federal- and state-level regulatory policies.