CONTACT
+91 80 2808 2808
info@biocon.com
Biocon  /  Businesses  /  Biosimilars  /  Insulin Glargine

BIOCON BIOSIMILARS

Committed to Making Insulins Available & Accessible

Biocon Biologics and Viatris Inc. Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn injection) for the Treatment of Diabetes
Interchangeable Designation Allows Substitution at the Pharmacy Counter for Lantus® Across the U.S. to Help Increase Access to Medicines for People Living with Diabetes
Company is Eligible for 12 Months of First Interchangeable Exclusivity from the Date of Commercial Launch

As a credible, global insulins player, Biocon Biologics has made sure-footed progress towards its mission of providing a high quality, affordable insulin analog for people with diabetes globally with the historic U.S. approval for the first interchangeable biosimilar Insulin Glargine.

Semglee®*, Insulin Glargine co-developed by Biocon Biologics and Viatris, had received U.S. Food and Drug Administration (FDA) approval  in June 2020 and was launched in August 2020 in vial and pre-filled pen presentations.

In July 2021, Semglee®* became the first interchangeable biosimilar product under the 351(k) regulatory pathway of the U.S. FDA.

This interchangeability approval for Semglee®* by the U.S. FDA, another first to Biocon Biologics’ credit, is a testament to the Company’s scientific excellence and robust quality comparability data.

It is a gamechanging achievement for both Biocon Biologics and partner Viatris. It will allow substitution of the product at the pharmacy counter, thus expanding patient access.

Kiran Mazumdar-Shaw

“We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S. It is a milestone achievement for both Biocon Biologics and our partner Viatris.”
– Biocon Biologics Executive Chairperson Kiran Mazumdar-Shaw.

More  

Arun Chandavarkar

“This interchangeability approval for Semglee®* by the U.S. FDA, another first to our credit, is a testament to our scientific excellence and robust quality comparability data.”

– Biocon Biologics Managing Director Arun Chandavarkar

More  

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. It received a historic U.S. approval as the first interchangeable biosimilar in July 2021.

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.

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

the basics of biosimilars

The Basics of Biosimilars

What are biosimilar products, and why are they important to the health care and patient communities? Learn more with Leah Christl, Ph.D., Associate Director for Therapeutic Biologics and lead of the Office of New Drugs (OND) Therapeutic Biologics and Biosimilars staff at FDA CDER.

Video Source: U.S. FDA YouTube
The Concept of Interchangeability

The Concept of Interchangeability

U.S. FDA approves the interchangeability of biosimilar products only after rigorous research and evaluation. Learn more with Leah Christl, Ph.D., Associate Director for Therapeutic Biologics and lead of the Office of New Drugs (OND) Therapeutic Biologics and Biosimilars staff at FDA CDER.

Video Source: U.S. FDA YouTube
The Promise of Biosimilars

The Promise of Biosimilars

What are the promises that biosimilars offer? More options, better patient access, and cost competition. Learn more with FDA Commissioner Scott Gottlieb, M.D., and Leah Christl, Ph.D., Director of the Office of New Drugs (OND) Therapeutic Biologics and Biosimilars Staff.

Video Source: U.S. FDA YouTube
Data Requirements for Biosimilars

Data Requirements for Biosimilars

FDA-approved biosimilars require data from multiple studies and analytical tools to demonstrate analytical similarity to reference products. Learn more with Dr. Steve Kozlowski, M.D., Director at FDA’s Center for Drug Evaluation and Research.

Video Source: U.S. FDA YouTube

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.

CORPORATE GOVERNANCE
KEY THERAPEUTIC AREAS
RESEARCH SERVICES
OUR CULTURE
RESPONSIBILITY
Share
Previous Next
Close
Test Caption
Test Description goes like this