Biocon, Mylan Launch Semglee and Seek Biosimilar, Interchangeable Status

Biocon Biologics and Mylan said they have launched the long-acting insulin glargine product Semglee on the US market and hope to obtain formal biosimilar status for it. Semglee was approved in June as an equivalent to Sanofi’s Lantus insulin glargine, but not as a biosimilar, owing to the regulatory pathway taken.

It has been launched at a deep discount to the reference product and arrives at a time of great pushback against high insulin prices and limited competition. Many public and private health plans have been lowering out-of-pocket costs for patients to ensure access to this essential medicine.

Available in vials and prefilled pens, Semglee is for the control of high blood sugar in adult and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. It is not recommended for patients with diabetic ketoacidosis.

Not a Full-Fledged Biosimilar

Although considered a biosimilar in other markets, Semglee doesn’t exactly qualify as such in the United States. It was approved via a new drug application under the Hatch-Waxman Act, a pathway traditionally used for generics and some biologics, including insulins. Because insulin approvals are now governed by the Biologics Price Competition and Innovation Act (BPCIA), and have been since March 2020, Semglee is now “deemed” a biologic.

“We are proud to be the first company, following the reference product, to receive FDA approval on and launch both the vial and pen presentations of an insulin glargine treatment with an identical amino acid sequence to Sanofi's Lantus,” said Mylan CEO Heather Bresch. She estimated the potential market for Semglee at 30 million Americans.

Mylan said it aims to have Semglee declared a full-fledged biosimilar to Lantus and has filed “all necessary documentation” to the FDA under the 351(k) pathway, which is the official BPCIA route for biosimilar approval. In addition, Mylan said it “remains confident in seeking an interchangeability designation” for the product as well.

Interchangeable designations allow pharmacists to fill prescriptions with biosimilars without consulting the prescribing physician. No current biosimilars have the interchangeable designation. It has been argued that there is such a high level of comfort with the safety and efficacy profile of insulins that approved products should be treated as interchangeable with originator products. Interchangeability would also speed the uptake of competing products.

Priced for Market Acceptance

To boost market acceptance of Semglee, Mylan, which serves as Biocon Biologics’ distribution partner in the United States, is offering packages of five 3-mL Semglee pens at the wholesale price of $147.98 and 10-mL individual vials at $98.65, which it called the lowest wholesale costs for any long-acting insulin glargine on the market.

“The list price of Semglee pen is equivalent to the Lantus launch price in 2007, and the Semglee vial is listed at Lantus’ 2010 pricing,” Mylan said in a statement. The individual vial cost of Lantus has climbed from $244 in 2013 to $431 in 2019, a 77% increase, according to a Senate Finance Committee letter.

Patient assistance programs or co-pay cards may further lower the cost, the statement said.

“We believe the US market represents a great opportunity for us and expect Semglee to contribute significantly to our goal of impacting 5 million patient lives and achieving $1 billion revenue by end of [fiscal year 2022],” said Christiane Hamacher, CEO of Biocon Biologics.

Semglee was approved based on analytical, preclinical, and clinical studies that confirmed the pharmacokinetics and pharmacodynamics, efficacy, safety, and immunogenicity of Semglee in comparison with Lantus in patients with type 1 and type 2 diabetes.