Insulin glargine-yfgn - Biologic Drug Details

Summary for insulin glargine-yfgn

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

Pharmacology for insulin glargine-yfgn

Established Pharmacologic Class	Insulin Analog
Chemical Structure	Insulin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insulin glargine-yfgn Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin glargine-yfgn Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for insulin glargine-yfgn Derived from Patent Text Search

No patents found based on company disclosures

Insulin Glargine-Yfgn: Market Dynamics and Financial Trajectory

Introduction to Insulin Glargine-Yfgn

Insulin glargine-yfgn, marketed as Semglee, is a significant development in the treatment of diabetes, particularly as the first interchangeable biosimilar insulin product approved by the U.S. Food and Drug Administration (FDA)[2][5].

Market Size and Growth Projections

The global insulin glargine market, which includes biosimilar products like Semglee, is anticipated to experience substantial growth. As of 2022, the market was valued at approximately USD 1.29 billion and is projected to reach USD 2.2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.11% during the forecast period (2023-2031)[1].

Alternatively, another projection estimates the global insulin glargine market to be valued at USD 5.45 billion in 2024 and to reach USD 8.43 billion by 2031, with a CAGR of 6.4% from 2024 to 2031[4].

Drivers of Market Growth

Increasing Prevalence of Diabetes

The global rise in diabetes prevalence, largely due to sedentary lifestyles and other lifestyle factors, is a primary driver of the insulin glargine market. As more people are diagnosed with diabetes, the demand for effective and affordable insulin treatments increases[1][4].

Regulatory Approvals and Interchangeability

The FDA's approval of Semglee as an interchangeable biosimilar to Lantus (insulin glargine) has opened up new avenues for market growth. This designation allows Semglee to be substituted for Lantus without a prescription from the healthcare provider, making it a more accessible and potentially cost-effective option for patients[2][5].

Technological Advancements

Advancements in drug delivery devices, such as wearable and smart insulin pens and pumps, are expected to support the growth of the insulin glargine market. These innovations enhance patient compliance and improve glycemic control[4].

Patent Expirations

The expiration of patents for major insulin brands has paved the way for the introduction of biosimilar insulin products. This shift is expected to increase market volume and provide more affordable options for patients[4].

Market Challenges

Adoption Rates

Despite the approval and potential benefits of biosimilar insulins like Semglee, the adoption rate has been slower than expected. Currently, Semglee holds around 10% market share, which is lower than anticipated given the significant cost challenges faced by insulin-dependent patients[3].

Regulatory Hurdles

Stringent regulations for the approval of insulin products can slightly hamper market growth. The rigorous testing and approval process required for biosimilar insulins can delay their entry into the market[4].

Patient Rationing

The issue of insulin rationing remains a significant challenge. Nearly 20% of Americans with diabetes resort to rationing their insulin, highlighting the need for more affordable and accessible insulin options[3].

Financial Impact

Cost-Effectiveness

The introduction of biosimilar insulins like Semglee is expected to be cost-effective, providing patients with safe, high-quality alternatives to branded insulins. This could lead to significant cost savings for both patients and healthcare systems[2][5].

Market Share and Competition

As more biosimilar insulins gain approval and enter the market, competition is likely to increase. Manufacturers will need to leverage the interchangeability designation as a competitive advantage to capture a larger market share[3].

Clinical Efficacy and Safety

Clinical Outcomes

Semglee has been shown to produce the same clinical results as Lantus, with no greater risk in terms of safety or diminished efficacy when switching between the two products. This equivalence ensures that patients can switch to Semglee without compromising their glycemic control[5].

Common Side Effects

The most common side effects associated with insulin glargine products, including Semglee, are hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions such as injection site reactions and rash[5].

Industry Expert Insights

Industry experts highlight the importance of biosimilar insulins in addressing the affordability crisis in diabetes treatment. "The approval of Semglee as an interchangeable biosimilar is a significant step towards providing patients with more affordable and accessible treatment options," said a spokesperson from Mylan Pharmaceuticals Inc.[2].

Illustrative Statistics

• Market Value: The global insulin glargine market is projected to reach USD 8.43 billion by 2031[4].
• CAGR: Expected to grow at a CAGR of 6.4% from 2024 to 2031[4].
• Adoption Rate: Semglee currently holds around 10% market share[3].
• Patient Rationing: Nearly 20% of Americans with diabetes resort to insulin rationing[3].

Key Takeaways

• The global insulin glargine market is expected to grow significantly due to increasing diabetes prevalence and the introduction of biosimilar products.
• Semglee, the first interchangeable biosimilar insulin, offers a cost-effective alternative to branded insulins.
• Technological advancements in drug delivery devices and patent expirations of major insulin brands are driving market growth.
• Despite potential benefits, the adoption rate of biosimilar insulins has been slower than expected.
• Regulatory hurdles and patient rationing remain significant challenges.

FAQs

What is insulin glargine-yfgn?

Insulin glargine-yfgn, marketed as Semglee, is a biosimilar insulin product that is interchangeable with Lantus (insulin glargine), a long-acting insulin analog.

What is the significance of the FDA's approval of Semglee?

The FDA's approval of Semglee as an interchangeable biosimilar allows it to be substituted for Lantus without a prescription, providing patients with a safe, high-quality, and potentially cost-effective treatment option.

What are the common side effects of insulin glargine products?

Common side effects include hypoglycemia, edema, lipodystrophy, weight gain, and allergic reactions such as injection site reactions and rash.

Why is the adoption rate of biosimilar insulins slower than expected?

The adoption rate is slower due to various factors, including the complexities within U.S. pharmaceutical channels and the significant cost challenges faced by insulin-dependent patients.

How does Semglee compare to Lantus in terms of clinical efficacy and safety?

Semglee has been shown to produce the same clinical results as Lantus, with no greater risk in terms of safety or diminished efficacy when switching between the two products.

Sources:

1. Straits Research - Insulin Glargine Market Size to Reach 2200 Million by 2031
2. Endocrine News - New Report Highlights Reveal Future of Insulin Biosimilars
3. Cardinal Health - 2023 Biosimilars Report
4. Coherent Market Insights - Insulin Glargine Market Size and Trends
5. FDA - FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes