Biocon Biologics Ltd., a subsidiary of India’s Biocon Ltd., has deepened its collaboration with U.S.-based nonprofit Civica Inc. to roll out a private-label version of insulin glargine in the United States. The initiative marks a strategic effort to make affordable insulin more accessible to millions of Americans, particularly those struggling with the rising cost of diabetes medication.

Under this multi-year agreement, Biocon Biologics will manufacture and supply insulin glargine—a long-acting insulin used to control blood sugar levels—to Civica, which will market the product under its own label. In California, it will be available under the CalRx brand, a program launched by the state to promote low-cost prescription drugs for residents.

The partnership underscores the growing global emphasis on health equity and accessibility, particularly in chronic disease management. With insulin costs long criticized as prohibitive in the U.S., this move signals a major step toward reshaping the insulin market through biosimilar innovation and transparent pricing.

🩺 STORY HIGHLIGHTS

• Biocon Biologics partners with Civica to expand low-cost insulin access in the U.S.

• Insulin glargine to be marketed under Civica’s private label; in California, as CalRx insulin.

• No technology transfer—Biocon retains IP rights and marketing authorization.

• FDA-approved biosimilar insulin glargine-yfgn, first interchangeable version of Sanofi’s Lantus.

• Civica’s mission: affordable, transparent insulin for underserved U.S. populations.

• Diabetes impact: Over 38.4 million Americans have diabetes; nearly 98 million are prediabetic.

Expanding Affordable Insulin Access

The financial terms of the insulin glargine deal were not disclosed, but the companies confirmed that no technology transfer is part of the agreement. Biocon Biologics retains all intellectual property and marketing rights, ensuring continuity in its biosimilar insulin portfolio.

This latest collaboration builds on an earlier supply arrangement under which Biocon Biologics provided insulin drug substances to Civica for U.S. production. The strengthened partnership reinforces Civica’s long-standing goal—to make high-quality, low-cost insulin available to every patient who needs it.

“This partnership represents a significant milestone in our insulin initiative,” said Ned McCoy, CEO of Civica. “Our mission is simple—bring transparency, affordability, and reliability to insulin access in the U.S. healthcare system.”

Civica’s nonprofit model is designed to challenge market monopolies by eliminating hidden costs and focusing solely on patient affordability. The company’s approach has already drawn attention from healthcare systems and policymakers nationwide.

FDA-Approved Biosimilar Strengthens Biocon’s Global Presence

Biocon Biologics’ insulin glargine-yfgn—approved by the U.S. FDA in July 2021—was the first interchangeable biosimilar to Sanofi’s Lantus, one of the most widely used insulin products globally. The biosimilar is approved for glycemic control in both adults and children with diabetes mellitus.

Biocon Biologics confirmed it will continue marketing its own version of insulin glargine in the U.S., alongside Civica’s private-label variant. This dual distribution strategy could help broaden patient reach while ensuring price stability across pharmacy networks.

Globally, Biocon Biologics ranks as the fourth-largest insulin producer, having delivered over 9.2 billion doses across 120 countries. The company’s biosimilar portfolio, covering basal, mixed, and rapid-acting insulins, has positioned it as a key player in the worldwide effort to democratize access to essential biologic medicines.

“At Biocon Biologics, we are driven by the mission of affordable healthcare for all,” a company spokesperson said. “Our partnership with Civica reflects that commitment by ensuring more Americans can access quality insulin without financial burden.”

Tackling America’s Diabetes Burden

The United States faces an escalating diabetes crisis, with 38.4 million people—roughly 11.6% of the population—living with the condition, according to the Centers for Disease Control and Prevention (CDC). Alarmingly, nearly one in four cases remain undiagnosed, while another 97.6 million Americans are prediabetic.

The high cost of insulin has long been a barrier to consistent treatment, forcing many patients to ration doses or skip them entirely. By introducing a low-cost, high-quality biosimilar insulin glargine, Biocon Biologics and Civica aim to bridge this critical affordability gap.

Founded in 2018 by U.S. health systems and philanthropies, Civica operates a state-of-the-art sterile injectable facility in Virginia. Its partnerships with global biopharmaceutical manufacturers like Biocon Biologics could reshape the way essential medicines are distributed and priced in the American market.

Toward a Transparent Future in Diabetes Care

As healthcare affordability continues to dominate U.S. policy debates, collaborations like that of Biocon Biologics and Civica offer a roadmap for patient-centric reform. Their initiative represents more than a supply deal—it reflects a shift in the global insulin economy, where innovation meets accessibility.

If successful, the partnership could set a precedent for how biosimilars are leveraged to lower costs without compromising quality—bringing hope to millions of Americans who depend on insulin for survival.

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