Approval of first interchangeable biosimilar insulin to increase competition with payer contracts: GlobalData

When it comes to insulin choice, price is currently the biggest barrier, as insulin brand preference is primarily determined not by a doctor, but through payer contracts with pharma companies, according to GlobalData. The company, in a statement, said that while patients will be increasingly prescribed Viatris/Biocon’s Semglee (biosimilar insulin glargine-yfgn) over Sanofi’s Lantus (insulin glargine) due to its competitive pricing, Semglee’s commercial success will be limited due to the declining use of the first-generation long-acting insulins.

Samisha Khangaonkar, Pharma Analyst, GlobalData, commented, “Semglee was first approved in 2020 by the US Food and Drug Administration (FDA) as a follow-on biologic, and it is the cheapest biosimilar of Lantus available in the market. Eli Lilly’s Basaglar (insulin glargine), the first-to-market biosimilar insulin (follow-on biologic in the US), is around 22 per cent cheaper than Lantus, whereas Semglee is roughly 64 per cent cheaper than Lantus in the US based on its wholesale acquisition cost.

“However, due to the contracts that payers develop with companies and the specific type of insurance held by patients, Lantus, Basaglar, or even Novo Nordisk’s Levemir (insulin detemir) may be cheaper for patients, despite Semglee’s heavy wholesale price reduction. Without interchangeability, prescribers need to specifically name the biosimilar over the reference product in a prescription, which limits the potential for biosimilars to gain market share and compete based on price.”

The statement also said that the US only recently opened the 351(K) designated biosimilar pathway for approval. In May 2019, as outlined in The Biologics Price Competition and Innovation Act of 2009, the FDA began receiving applications via its new biosimilar pathway. Prior to the launch of this pathway, therapeutics that were highly similar to a reference product would need to apply to the FDA as a follow-on biologic.

This interchangeability designation now allows pharmacies to substitute the cheaper therapeutic for patients, regardless of what is on the prescription, much like how generic drugs are routinely substituted for brand-name drugs. This is commonly called pharmacy-level substitution and is subject to state pharmacy laws, added the statement.

Khangaonkar continued, “This new pathway, and its interchangeability designations, will allow for more biosimilars to not only receive expedited approval, but to potentially receive an interchangeability designation and increase the price competition with its branded originator. Despite this interchangeability designation, access to the lower pricing of Semglee is entirely dependent on Viatris’ ability to negotiate with private payers in the US.

Some key opinion leaders have noted a general hesitancy to prescribe insulins from unfamiliar manufacturers, which has limited the uptake of biosimilar insulin.

Khangaonkar also said, “Lantus has been the gold-standard long-acting insulin analogue and is still the long-acting insulin with the greatest patient shares across type-I and type-II diabetes. It will be important for Viatris to capitalise on the interchangeability designation to establish itself early on, as the overall patient shares of insulin glargines are expected to decrease over the next ten years.”

Diabetes patients are increasingly switched to insulin pumps, where they will not need a long-acting insulin, or are transitioned from first-generation long-acting insulin analogues like Lantus, to the second-generation long-acting analogues like Sanofi’s Toujeo (insulin glargine U300) or Novo Nordisk’s Tresiba (insulin degludec), which have demonstrated fewer incidences of hypoglycemia. Viatris’ price point, and its potential impact on compliance, will play an important role in its inclusion in private payer formularies, mentioned the statement.

It also notified that Sanofi’s 2019 departure from further investment in its diabetes portfolio provides an opportunity for Viatris. Viatris is a subsidiary of Pfizer, and payer contracts tend to go to more established pharmaceutical companies in the diabetes space like Novo Nordisk, Eli Lilly and Sanofi.

Khangaonkar added, “While Pfizer is not an established player in the insulin space, we expect that it 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 pharmaceutical space. According to interviewed payers, the currently very competitive pricing of Semglee, coupled with the increased biosimilar trust demonstrated through the interchangeability designation, will make it harder for Lantus to compete and will likely encourage payers to develop biosimilar contracts with Viatris/Pfizer.”