Semglee®*: The U.S. Journey

The New Drug Application (NDA) for Insulin Glargine was filed under the 505 (b)(2) pathway with the U.S. FDA in 2017. In early 2020, the U.S. added insulins to the list of biologics to be approved under the Biologics Price Competition and Innovation Act (BPCIA) approval pathway. Semglee®* was approved as a drug product under the 505(b)(2) pathway in U.S. and deemed a biologic under Section 351(a) in accordance with the BPCIA in June 2020. Semglee®* was launched in vial and pre-filled pen presentations in the U.S. in August 2020.

In July 2021, our biosimilar Insulin Glargine received a historic U.S. approval as the first interchangeable biosimilar under the 351(k) regulatory pathway. Our partner Viatris launched this first-ever interchangeable biosimilar Glargine in the U.S. in November 2021, thus providing a more affordable option for millions of Americans living with diabetes.

The U.S. FDA has set a high scientific bar for granting interchangeability status, with biosimilar developers required to submit results from switching studies that evaluate patient responses when they switch between reference to biosimilar and back to reference product, in order to ensure that there is no compromise of patient safety. The interchangeable designation will thus improve the confidence of prescribers, patients and payors in our biosimilar Insulin Glargine.

Already, our interchangeable product has been included in the National Formularies of two leading Pharmacy Benefit Manager (PBM) in the U.S., Express Scripts and Prime Therapeutics, which together have a reach of over 60 million members. The product will also be offered through the Walgreens Prescription Savings Club, saving members up to 80 percent off the cash price of comparable long-acting insulins purchased at Walgreens.

We believe our biosimilar Insulin Glargine has the potential to bring significant cost savings for patients, employers and PBMs, making insulin-based therapy accessible for a larger number of people with diabetes in the U.S.

FDA NEWS RELEASE

FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
Availability of Insulin Products Will Help Increase Access and Potentially Lower the Cost of Insulin for People with Diabetes

Extract from U.S. FDA News Release

For Immediate Release: July 28, 2021

Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilar and interchangeable biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.

“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of Types 1 and 2 diabetes mellitus,” said Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”

Source: U.S. FDA News Release: July 28, 2021.  Read More

Insulin Glargine: Key Timelines

• 2009: Biocon launched Insulin Glargine (Basalog®) in India, expanding the basket of insulin products available for people with diabetes in the country.
• 2016: Biocon’s Insulin Glargine pen launched in Japan as the first biosimilar from India.
• 2017: New Drug Application (NDA) for Semglee®* (Biosimilar Insulin Glargine, co-developed with Mylan) was filed under the 505 (b)(2) pathway with the U.S. FDA.
• 2018: European Commission gave marketing approval to Semglee®*; product commercialized in Europe by partner.
• June 2020: Semglee®* approved as a drug product under the 505(b)(2) NDA pathway in U.S., deemed a biologic under Section 351(a) in accordance with the BPCIA in line with other insulin products.
• August 2020: Semglee®* launched in vial and pre-filled pen presentations in U.S.; Semglee®* offered at the lowest wholesale acquisition cost (WAC) for any long-acting Insulin Glargine on the U.S. market.
• July 2021: Semglee®* received historic U.S. approval as the first interchangeable biosimilar.
• November 2021: Branded and unbranded versions of the first-ever interchangeable biosimilar launched in the U.S.

Why is Interchangeability Important

This interchangeability approval is important for products like insulin and insulin analogs that cater to a chronic disease, diabetes. By allowing pharmacies to switch prescriptions from the innovator brand to biosimilars product, it can improve market penetration of biosimilar alternatives. It can also improve the confidence of prescribers, patients and payors in biosimilars.

Learn More About Biosimilars & Interchangeability

Read More About Our Insulin Glargine:

Biocon and Viatris were among the first few to receive approval for biosimilar Insulin Glargine in Europe. Semglee®* (Insulin Glargine) was the first biosimilar from Biocon and Mylan’s joint portfolio to be approved in Europe. Read More  

*Co-developed with Viatris.