Supporting reliable insulin access
As the demand for insulin therapy continues to grow, healthcare stakeholders face increasing pressure to ensure consistent patient access to insulin therapy. Lanexa Biologics is focused exclusively on biosimilar insulin, bringing together scientific expertise, experienced pharmaceutical leadership, and strategic manufacturing partnerships to help expand access to high-quality insulin therapies across the United States.
Helping patients access the insulin they need.
Lanexa Biologics was created to help expand patient access to high-quality biosimilar insulin therapies in the United States. We are dedicated to advancing biosimilar insulin therapies, bringing focused expertise to one of medicine’s most essential therapies. Our exclusive focus on biosimilar insulin therapies allows us to devote our scientific, regulatory, commercial and operational expertise to enhancing diabetes care.
Our insulin platform is built around the development and commercialization of biosimilar insulin therapies that address the ongoing need for affordable, reliable insulin access. The portfolio includes biosimilar insulin glargine and insulin aspart, developed through a strategic co-development and commercialization partnership.
Mission
Our mission is to improve the lives of people living with diabetes by expanding access to affordable, high-quality biosimilar insulins for the U.S. market.
Commitment
Lanexa Biologics is committed to advancing high-quality biosimilar insulin therapies by ensuring:
- Scientific and regulatory rigor
- Reliable manufacturing and supply continuity
- Responsible commercialization
- Long-term partnerships to support operational excellence
Leadership team
Lanexa Biologics’ leadership team brings together experienced pharmaceutical executives with expertise spanning biologics, regulatory affairs, commercial operations, manufacturing, quality, and market access. Collectively, the team has more than 100 years of experience developing, manufacturing, and commercializing pharmaceutical products for the U.S. healthcare market.
Meet the team
CEO
Tony Meehan
Development
Steven Lehrer
Commercial
Michael Pestorius
Supply Chain & Quality
John M. Abt
What is a biosimilar?1
Biosimilars are biologic medicines that are highly similar to an FDA-approved reference product and are developed to meet rigorous standards for quality, safety, efficacy, and clinical performance.
The FDA evaluates biosimilars using extensive analytical, nonclinical, and clinical data to confirm there are no clinically meaningful differences between the biosimilar and its reference product.
Certain biosimilars may also receive an interchangeability designation from the FDA. An interchangeable biosimilar may be substituted at the pharmacy level in accordance with applicable state laws and regulations.
Biosimilars are expected to provide important benefits for patients and the healthcare system by increasing treatment options and promoting competition. Increased competition may help improve affordability, expand patient access to critical therapies, and support a more stable and sustainable supply of important medications, including insulin products.
Expertise in biosimilar development and manufacturing
LANGLARA is manufactured by Sunshine Lake Pharma, a leading biopharmaceutical company with advanced biologics and insulin manufacturing capabilities and extensive experience supporting pharmaceutical products for global markets.
As part of its partnership with Lanexa Biologics, Sunshine Lake Pharma has established a purposebuilt manufacturing facility dedicated to the production of biosimilar insulin for the U.S. market. Designed and operated to meet FDA regulatory standards, the facility provides the manufacturing foundation to ensure a robust and reliable supply of LANGLARA and future biosimilar insulin therapies.
An integrated insulin platform
Expanding access to biosimilar insulin requires more than developing a high-quality medicine. It requires expertise in biologics manufacturing, insulin pen technology, and U.S. commercialization.
In addition to our strategic insulin manufacturing partnership with Sunshine Lake, we are also proud to partner with Ypsomed AG, a global leader in the development and production of insulin pens and self-injection systems.
Lanexa Biologics brings together three organizations with complementary capabilities to deliver new therapies to the U.S. market. Our strategic partnership with Sunshine Lake Pharma provides advanced insulin manufacturing expertise, while our collaboration with Ypsomed AG provides dedicated insulin pen manufacturing capabilities. Together, these partnerships support current production capacity of approximately 15–18 million prefilled insulin pens annually, with the ability to expand as demand grows. Our collaborations with Sunshine Lake and Ypsomed reflect a shared commitment to quality, reliability, and manufacturing excellence.
1.U.S. Food and Drug Administration. Biosimilar and interchangeable biologics: more treatment choices. Available at: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices. Accessed May 18, 2026.
The evolving diabetes landscape
Due to the increasing incidence of diabetes, diabetes represents a major health crisis in the United States, despite advances in treatment and prevention.1 Tens of millions of Americans are living with diagnosed diabetes, and millions more have yet to be diagnosed.2 Without proper management, diabetes can cause kidney failure, vision loss, nerve damage, and heart disease—risks that can be reduced with the access and consistent use of the right treatment, including insulin therapy.1
>40 million
patients are living with diabetes in the U.S., representing 12% of the U.S. population, including2:
29.1 million diagnosed patients
11 million undiagnosed patients
1.5 million
patients are diagnosed every year2
115 million
American adults are living with prediabetes2
7.5 million
people require insulin3
Due to the increasing rate of diabetes in the U.S. and changes in treatment patterns, the demand for insulin is significant and intensifying.2,4
The need for new biosimilar insulin therapies
While the need for insulin is increasing, insulin manufacturing remains concentrated among a limited number of companies, some of whom are exiting the insulin market or discontinuing production of specific insulin therapies, reducing resilience in insulin supply chains and leading to insulin shortages.
The result is a market in which the demand is growing,4 existing options are decreasing,5 and safe and affordable alternatives are needed.
To meet these evolving needs, Lanexa Biologics has partnered with two world class companies to develop a biosimilar insulin platform that is focused, operationally grounded, and designed to support broader access to patients who need insulin therapy.
Increasing number of insulin options, which could make insulin more widely available8,9
More insulin options could reduce the risk of insulin shortages9-11
Reduced insulin cost8,9
Improved patient access to insulin9
References
1. Rowley WR, Bezold C, Arikan Y, Byrne E, Krohe S. Diabetes 2030: insights from yesterday, today and future trends. Popul Health Manag. 2017;20(1):6-12. doi: 10.1089/pop.2015.0181.
2. American Diabetes Association. About diabetes: statistics about diabetes. Available at: https://diabetes.org/about-diabetes/statistics/about-diabetes. 3. Borden CG, Bakkila BF, Nally LM, Lipska KJ. The association between cost-related insulin rationing and health care utilization in U.S. adults with diabetes. Diabetes Care. 2025;48(3):400-404. doi: 10.2337/dc24-2117. 4. Wang Y, Bullard KM, Zhang P. National trends in expenditures on glucose- lowering medications in U.S. adults with diabetes: 2000-2022. Diabetes Care. 2026;1;49(4):571-577. doi: 10.2337/dc25-2016. 5. Barber M, Sofides A, Ramachandran R. Counting on insulin manufacturers to do the right thing is not a good policy prescription to avert shortages. Health Affairs Forefront. July 12, 2024. Available at: https://www.healthaffairs.org/content/forefront/counting-insulin-manufacturers-do-right-thing-not-good-policy-prescription-avert. 6. American Society of Health System Pharmacists. Current drug shortages: insulin detemir injection. January 13, 2025. Available at: https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=1006. 7. American Society of Health System Pharmacists. Current drug shortages: insulin glargine injection (recombinant). Available at: https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=1133.
8. U.S. Food and Drug Administration. Biosimilar and interchangeable biologics: more treatment choices. Available at: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices. Accessed May 18, 2026. 9. Joshi SR, Mittra S, Raj P, Suvarna VR, Athalye SN. Biosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know. Insulins perspective. Expert Opin Biol Ther. 2023;23(8):693-704. doi: 10.1080/14712598.2022.2112664. 10. Dranitsaris G, Jacobs I, Kirchhoff C, Popovian R, Shane LG. Drug tendering: drug supply and shortage implications for the uptake of biosimilars. Clinicoecon Outcomes Res. 2017;9:573-584. doi: 10.2147/CEOR.S140063. 11. Li E, Subramanian J, Anderson S, Thomas D, McKinley J, Jacobs IA. Development of biosimilars in an era of oncologic drug shortages. Drug Des Devel Ther. 2015;9:3247-55. doi: 10.2147/DDDT.S75219.
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