Viatris, Biocon snare historic interchangeability tag in diabetes for Lantus biosimilar

Biosimilars have been quietly moderating drug prices in the background, Bernstein analyst Ronny Gal said in a recent report. Now, armed with their first biosimilar green light of 2021, Biocon and Viatris, the company born from the combination of Mylan and Pfizer's Upjohn unit, are plotting to disrupt the historically pricey insulin market. 

The FDA on Wednesday approved Biocon and Viatris’ Semglee as the first interchangeable biosimilar. Also known as insulin glargine-yfgn, the drug references Sanofi’s blockbuster diabetes med Lantus. Its interchangeability tag means it can be subbed for Sanofi’s product at the pharmacy without a doctor’s prescription, similar to how patients receive generic versions of brand-name small-molecule drugs.

Many diabetes patients depend on insulin to manage their disease, but the meds are pricey, making lower-cost biosimilars an attractive alternative. Viatris didn’t say whether the new approval would shift the drug’s price tag, but Semglee in its current form, which was approved in June 2020 for Type 1 and Type 2 diabetes, costs somewhere between $98.65 and $112 for a 10-ml vial, according to public sources.

By comparison, Lantus costs around $306 for a 10-ml supply before discounts. Biosimilars sold in the U.S. have typically launched with list prices between 15% and 35% lower than those of their reference products, the FDA said in a release.

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Viatris plans to make interchangeable Semglee available before the end of the year and says it’s eligible for 12 months of exclusivity before the FDA can sign off on another interchangeable Lantus copycat. It aims to switch over its current Semglee product to the interchangeable version “over the next few months.” Launch preparations are underway, the company added.

The interchangeability tag is expected to improve access for patients, physicians, payers and providers, Michael Goettler, Viatris’ CEO, said in a statement. It also “sets the stage” for future insulin product approvals, said Arun Chandavarkar, managing director at Biocon Biologics.

Interchangeable biosimilars can be subbed for their brand-name counterparts right at the pharmacy counter, depending on state pharmacy laws, the FDA said in a biosim fact sheet issued alongside Wednesday’s approval. All states have enacted laws to set the standards for interchangeable biosim substitution, the American Journal of Managed Care’s Center for Biosimilars reports. Mainly, patients need to be informed that they’re getting a substitute.

Aside from its historic interchangeability designation, Semglee is also the first biosimilar that will be sold predominately in retail pharmacies, Jeff Baldetti, director of biosimilars at Cardinal Health, said over email. Semglee's green light marks an "exciting day" for the U.S. market, but continued biosim education for doctors, pharmacists and patients will be "critical," he added. 

Recognizing that need, the FDA has also released a healthcare provider fact sheet on biosimilars, plus new information for consumers about interchangeables, which references Semglee by name. 

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For the first time, retail pharmacists will "be tasked with playing a significant role counseling and educating their patients on biosimilar products," Baldetti noted. Beyond education, pharmacy benefit managers and payers' formulary policies will serve as either "catalysts or barriers" to the wider adoption of biosimilars "primarily billed under the pharmacy benefit," he said. 

The FDA gave Semglee the thumbs-up based on evidence showing it is “highly similar” to Lantus, with no clinically meaningful differences on metrics of safety, purity and potency. Safety and efficacy risks from switching between the two drugs is “not greater” than the risk of using Lantus alone, the regulator said.

Semglee comes in 10-ml vials and 3-ml prefilled pens and is given below the skin once a day. The drug was missing in action from Viatris' first quarter earnings report. Meanwhile, Sanofi's Lantus generated €652 million ($774.67 million) in the first quarter and reeled in €2.66 billion ($3.16 billion) in 2020. 

Editor's note: This story has been updated with additional comments from Cardinal Health.