However, the patent expiration of biologic products opens opportunities for the development of biosimilars. Biosimilars are the biologic drugs which resembles the marketed biological in terms of their quality specifications, safety profile, and efficacy parameters.
“US Biosimilar Insulin Market Opportunity & Clinical Trials Insight 2026” Report Highlights:
- US Diabetic Drug Market Opportunity: > US$ 35 Billion
- US Insulin Market Opportunity > US$ 10 Billion
- US Biosimilar Insulin Market Opportunity > US$ 1 Billion
- Approved Biosimilar Insulin: 2 (Semglee & Rezvoglar)
- US Biosimilar Insulin Market Cost Comparison Analysis
- First FDA Approved Interchangeable Biosimilar Insulin Cost & Dosage Insight
Diabetes is a non-communicable disease, or chronic disease, related to the body’s production and use of insulin. While insulin is naturally secreted by the pancreas in healthy individuals, people with diabetes cannot produce insulin, produce insufficient insulin, or do not respond to insulin and need other medication to control their blood sugar. The price of insulin in US is skyrocketing which is generally not affordable to large number of patients.
However, the patent expiration of biologic products opens opportunities for the development of biosimilars. Biosimilars are the biologic drugs which resembles the marketed biological in terms of their quality specifications, safety profile, and efficacy parameters. However, they are priced 15-40% lower than reference products, thus aiding in decreasing the cost of cancer therapy. The biosimilar insulin is processed in a way that it almost mimics the action of the original insulin product.
In July 2021, FDA has approved Biocon Biologic’s Semglee insulin glargine as an interchangeable biosimilar, referencing Lantus. An interchangeable designation means that Semglee can be substituted for Lantus automatically by pharmacists without physicians’ permission. It is indicated to control high blood pressure in adults with type-2 diabetes and pediatric patients with type-1 diabetes. The approval of Semglee is considered as breakthrough in biosimilar market as it is the first interchangeable biosimilar which has been approved by regulatory bodies.
In December 2021, US FDA approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar. Rezvoglar is biosimilar to Lantus (insulin glargine). Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. As a biosimilar product, Rezvoglar can be used in place of Lantus; however, the patient would need a prescription from a health care prescriber written specifically for Rezvoglar. This approval furthers FDA’s longstanding commitment to support a competitive marketplace for insulin products.
Despite having numerous benefits, the biosimilar drugs are faced with numerous challenges when they enter the market. Even though the biosimilar drugs have identical amino acid sequences to their reference products, but they considerably differ in their 3-D structure, glycosylation sites, isoform profiles and protein aggregation. Therefore, the pharmacodynamics and pharmacokinetic properties of biosimilars are evaluated to prove their biosimilarity to the reference products. In addition to this, patient awareness is also one of the major challenges to enter into the market. There is lack of knowledge among the population regarding the availability, interchangeability and cost benefits of the biosimilars drugs.
In the past few years, the volume of research, publications and number of clinical trials have increased significantly for the field as patents of most of the leading insulin are about to get expire very soon. The biosimilars of insulin aspart and insulin lispro is most likely to get market authorisation by the end of year 2023 while some of the combinational insulins are also believed to get approval in US. Several pharmaceutical companies in US including Harvest moon pharmaceuticals, Sanofi Bioepis and HEC Biopharm have invested a huge amount for the research activities focusing on insulin biosimilar, which will further boost the growth of market.
As per our report findings, US insulin biosimilar market is expected to surpass US$ 1 Billion by 2026. In US, the role of biosimilar insulin in diabetes management is currently at a nascent stage but this segment is believed to hold a major share in the US insulin market due to the presence of huge burden of diabetic population in this region while most of the market-related factors are also promoting the growth of this segment. The report US insulin biosimilar provides information on the available insulin biosimilar along with the clinical trial insights in this sector. In-depth analysis of various favorable parameters as well as challenges for the growth of insulin biosimilar market in US is also assessed. Furthermore, the report forecasts the future opportunities of the market during the year 2021-2026.
Contact:
Neeraj Chawla
Research Head
Kuick Research
+91-9810410366