Kiran Mazumdar-Shaw-led Biocon's plans to tap the insulin market in the U.S. got a fillip as Walgreens—the second-largest pharmacy chain in the U.S.—has agreed to sell its insulin injection branded as Semglee.
Semglee, launched in the U.S. on November 16, is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. Walgreens Prescription Savings Club will offer its members up to 80% off the cash price of comparable long-acting insulins purchased at Walgreens, Biocon has said.
A few weeks ago Express Scripts—a leading pharmacy benefit management organization (PBM or companies that manage prescription drug benefits on behalf of health insurers, employers etc in the U.S.)—has also listed Semglee as a preferred glargine brand on its National Preferred Formulary (NPF), which includes more than 28 million people.
Semglee (insulin glargine-yfgn injection) is the first interchangeable biosimilar product approved by the U.S. Food and Drug Administration (FDA) in the last week of July. As per the new biosimilar pathway approved by the U.S. FDA, therapeutics that are highly similar to a reference product will get a faster approval process as a follow-on biologic and is aimed to reduce healthcare costs. Biocon's historic approval allows substitution of Semglee for the reference product— Sanofi's blockbuster insulin injection Lantus—at the pharmacy counter.
Biocon's subsidiary Biocon Biologics and its partner Viatris is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. The U.S. insulin market is projected to grow to a size of $30 billion by 2025. For Sanofi, Lantus had generated $2.7 billion in sales worldwide in 2020.
Sources say Biocon and its partner Viatris—(Viatris was formed through the merger of Mylan and Upjohn, a division of Pfizer in November last year, Biocon and Mylan were working together for a few products for the U.S. market)—are rolling out the interchangeable insulin for Lantus in the U.S. market in two versions—one as branded and the other as unbranded. The wholesale acquisition cost (WAC) for a package of five 3-ml pens is priced less than $150, about 65% cheaper than the branded Lantus. Branded Semglee will be slightly cheaper than the reference product, they have said.
Biocon Biologics—which now has three products launched in the US with Mylan—targets around $1 billion revenue by end of FY22, Christiane Hamacher, CEO & managing director of Biocon Biologics, had said in an earlier interview. Mylan and Biocon Biologics had earlier launched two complex biosimilars in the U.S.—Ogivri, the first biosimilar to Roche's cancer drug Herceptin and Fulphila (pegfilgrastim), the first biosimilar in the U.S. to Amgen's cancer drug Neulasta. Biocon is also expecting interchangeable approval from the FDA in the coming months for another insulin Kixelle, a biosimilar to Novo Nordisk’s NovoRapid/Novolog (insulin aspart).