Sandoz Wins EC Approval for Two Insulin Biosimilars

Sandoz has received European Commission marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), two biosimilar insulins for injection in prefilled pens developed by Gan & Lee Pharmaceuticals.

The approvals come amid a broader evolution in the biosimilar market. A recent HHS analysis confirmed that most biosimilar markets become economically unviable after five competitors. High-competition markets drive down costs for the highest-burden disease areas and deliver immediate savings to patients, but they cannot be the only game plan. Stories highlight nine adalimumab biosimilars launching in just one year, and a similar pattern with the ustekinumab market, hinting at pricing wars and unsustainable margins.

The first generation of biosimilar manufacturers made a logical bet: develop biosimilars for the highest-revenue biologics. That approach created overcrowded markets where price became the only differentiator, margins evaporated, and the resulting economics made sustained investment impossible. Most likely, the next billion-dollar biosimilar won't come from a top 10 blockbuster. Companies finding the most success today are building diversified portfolios across multiple therapeutic areas and molecular targets, which aligns more closely with what patients need.

Accord, with seven FDA-approved therapies and a pipeline built for scale, is driving toward an ambitious goal: 20 biosimilars to market by 2030 and a position as the leading biosimilar provider in the U.S. Payers and healthcare systems benefit from partners who can provide biosimilar options across the therapeutic areas they need, not just the most crowded ones.

Sandoz also presented its net-sales performance for the first quarter of 2026.