Introduction to Semglee
Semglee, an insulin glargine biosimilar developed by Viatris and Biocon Biologics, has been a significant player in the diabetes treatment market since its approval by the FDA. This biosimilar is designed to be interchangeable with Sanofi's Lantus, offering a potentially more affordable option for patients with diabetes.
Market Share and Adoption
Initial Uptake and Market Share
The adoption of Semglee has been a mixed bag. Before gaining the interchangeable designation, the non-interchangeable version of Semglee saw slow uptake, capturing only about 1% of the market share in the commercial space by November 2021. However, after receiving the interchangeable designation, Semglee's market share jumped to 15% of commercial prescriptions by March 2022[4].
In Medicare, Semglee and the unbranded Insulin Glargine have shown notable growth, increasing from 3% and 6% market share in March 2022 to 6% and 31%, respectively, by Q1 2023[1].
Payer Controls and Formulary Placement
Despite the growth, payer controls have significantly limited the adoption of Semglee. Less than one in five new prescriptions for biosimilar insulin glargine were filled with the biosimilar, largely due to formulary constraints and preferential treatment given to traditional manufacturers like Eli Lilly, Novo Nordisk, and Sanofi[1][2].
Pricing Strategy and Impact
List Prices and Wholesale Acquisition Costs (WAC)
Viatris has employed a dual-pricing strategy for Semglee. The brand-name Semglee has a WAC of $404.04 for a package of five 3-ml pens, which is only slightly cheaper than Lantus' list price of $425.31. The unbranded version, however, is priced at $147.98 for the same package, representing a 65% discount compared to Lantus[3][5].
Rebates and Net Prices
The pricing strategy involves substantial rebates paid to pharmacy benefit managers (PBMs) for the higher-priced version, while the lower-priced version comes with minimal or no rebates. This approach is designed to make the drug more attractive to PBMs, even though it may not significantly reduce the out-of-pocket costs for patients[3][5].
Cost Savings and Patient Impact
Semglee costs roughly one-third of the price of Lantus, offering significant cost savings for patients. For example, early projections suggested that a competitive biosimilar for insulin glargine could be sold at a profit for $5.32-$7.38 per 10 ml, a 91.4%-93.8% decrease from the listed price of $85.67 per 10 ml for Lantus in the United States[2].
Patient Assistance Programs
Viatris also offers patient assistance programs that could lower the cost of Semglee to $0 for a 30-day supply for commercially insured patients. Uninsured patients may also benefit from these programs, potentially receiving the medication for free[2].
Market Dynamics and Future Projections
Competition and Market Landscape
The launch of Semglee has highlighted the complex dynamics in the insulin market. The presence of multiple versions of the same product, each with different pricing and rebate structures, complicates the decision-making process for payers and patients. This strategy mirrors that of other pharmaceutical companies, such as Eli Lilly, which also offers different versions of its fast-acting insulins[3].
Future Biosimilar Competition
The experience with Semglee can provide insights into how future biosimilars, such as those for adalimumab, might be adopted. The adalimumab market will face multiple biosimilar competitors, each with different formulations and pricing strategies, which could further complicate the market landscape[4].
Key Findings and Challenges
Parity Access and Market Share
If Semglee had parity access, it would have achieved more than two-thirds of all new prescriptions in the commercial market and 60% market share of new prescriptions in the Medicare market. However, current formulary constraints limit this potential[1].
Payer Preferences
Pharmacy benefit managers often prefer higher-priced products with substantial rebates, which can limit the adoption of lower-priced biosimilars. This preference forces companies like Viatris to launch both high-priced and low-priced versions of their products to cater to different segments of the market[3].
Quotes from Industry Experts
David Steinberg, PharmD
"The FDA’s decision has created an overwhelmingly affordable long-acting insulin option for patients," said David Steinberg, PharmD, director of pharmacy insights at Scripta Insights. "Semglee costs roughly one-third of the price with the same safety and efficacy"[2].
Adam Fein, Ph.D.
"The coverage landscape has ‘forced’ Viatris to launch both a high-priced and low-priced version of its product," wrote Adam Fein, Ph.D., CEO of Drug Channels Institute. "Many commercial payers will adopt the more expensive product instead of the identical—but cheaper—version"[3].
Illustrative Statistics
- Market Share Growth: Semglee and unbranded Insulin Glargine have seen growth in Medicare from 3% and 6% in March 2022 to 6% and 31% market share, respectively, by Q1 2023[1].
- Price Comparison: The unbranded version of Semglee is priced at $147.98 for a package of five 3-ml pens, a 65% discount compared to Lantus[3].
- Cost Savings: Early projections suggest a competitive biosimilar for insulin glargine could be sold at a profit for $5.32-$7.38 per 10 ml, a 91.4%-93.8% decrease from the listed price of $85.67 per 10 ml for Lantus[2].
Conclusion
The introduction of Semglee has marked a significant shift in the insulin market, offering patients a more affordable alternative to traditional insulin products. However, the complex interplay between list prices, rebates, and formulary placements continues to influence the adoption and cost savings associated with this biosimilar.
Key Takeaways
- Dual Pricing Strategy: Viatris has launched both a high-priced and low-priced version of Semglee to cater to different market segments.
- Market Share Growth: Semglee has seen notable growth in market share, especially in Medicare.
- Cost Savings: Semglee offers significant cost savings compared to traditional insulin products.
- Payer Controls: Formulary constraints and payer preferences for higher-priced products with substantial rebates limit the full potential of biosimilar adoption.
- Future Projections: The experience with Semglee can provide insights into the adoption of future biosimilars.
FAQs
Q: What is Semglee and how does it compare to Lantus?
A: Semglee is an insulin glargine biosimilar that is interchangeable with Sanofi's Lantus. It offers a similar safety and efficacy profile at a lower cost, with the unbranded version being 65% cheaper than Lantus[3].
Q: How has the market share of Semglee evolved since its launch?
A: Semglee's market share has grown significantly, especially in Medicare, where it and the unbranded Insulin Glargine have increased their market share from 3% and 6% in March 2022 to 6% and 31%, respectively, by Q1 2023[1].
Q: What is the pricing strategy for Semglee?
A: Viatris has launched two versions of Semglee: a brand-name version with a WAC of $404.04 for a package of five 3-ml pens, and an unbranded version with a WAC of $147.98 for the same package[3].
Q: How do rebates affect the adoption of Semglee?
A: The higher-priced version of Semglee involves substantial rebates paid to pharmacy benefit managers, which can make it more attractive to these intermediaries, even though it may not reduce out-of-pocket costs for patients significantly[3].
Q: What are the potential cost savings for patients using Semglee?
A: Semglee can offer significant cost savings, with projections suggesting it could be sold at a profit for $5.32-$7.38 per 10 ml, a 91.4%-93.8% decrease from the listed price of $85.67 per 10 ml for Lantus[2].
Sources
- Biosimilars Council. Semglee Launch Tracking. August 14, 2023.
- Pharmacy Times. Biosimilar Semglee Could Spell Massive Changes for Net Cost of Insulin. August 11, 2021.
- Fierce Pharma. Viatris launched 2 versions of its interchangeable insulin biosimilar Semglee. November 16, 2021.
- Center for Biosimilars. IQVIA: Semglee Experience Can Help Predict Adalimumab Biosimilar Adoption. November 3, 2022.
- Axios. The new generic insulin isn't as cheap as you thought. November 17, 2021.
