Liraglutide Combination Products Incorporating Stevanato Group's Alina® Pen Injector Received Marketing Authorizations in Multiple European Countries

Key Terms

marketing authorizations regulatory

A marketing authorization is an official government approval that allows a company to sell a drug, medical device, or health product in a particular country or region. It matters to investors because it is the legal key to generate revenue and reach customers—like a driver’s license for a product—so obtaining, losing, or delaying authorization directly affects a company’s potential sales, regulatory risk and valuation.

liraglutide medical

Liraglutide is a prescription medication that mimics a natural gut hormone to help lower blood sugar and reduce appetite, used for treating type 2 diabetes and for chronic weight management. Investors pay attention because its clinical effectiveness, regulatory approvals, safety profile, patent status and market demand directly affect sales, pricing and competition in the large diabetes and obesity drug markets—think of it as a high-value product whose performance drives revenue and valuation.

glp-1s medical

GLP-1s are a class of prescription medicines that mimic a natural gut hormone to lower blood sugar, curb appetite and slow stomach emptying, often used for diabetes and weight management. They matter to investors because prescribing rates, pricing and insurance coverage can drive large, sustained revenue streams and reshape demand across drug makers, medical device vendors and health insurers—like a bestselling product line that shifts an entire market.

fill and finish technical

The final stage of producing biological medicines where bulk drug substance is transferred into final dosage forms—filling vials, syringes, or cartridges—and then sealed, labeled and packaged for distribution. It matters to investors because this step determines how quickly a treatment can reach patients, creates manufacturing bottlenecks or capacity value, and often involves specialized facilities and regulatory controls; think of it as the bottling and labeling line in a beverage plant that readies product for sale.

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The regulatory approvals cover therapies for diabetes and weight management, further expanding the commercial adoption of Stevanato Group's proprietary Alina^® pen injector platform across Europe.

PIOMBINO DESE, Italy--(BUSINESS WIRE)-- Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment, drug delivery and diagnostic solutions for the pharmaceutical, biotechnology and life sciences industries, today announced that liraglutide-based combination products incorporating Stevanato Group’s proprietary Alina^® pen injector platform have received marketing authorizations in Europe. The authorizations relate to finished combination products held by the respective Marketing Authorization Holders.

The approved configurations include Alina^® 30, developed for liraglutide-based therapies for diabetes, and Alina^® 50, designed for liraglutide-based weight management applications. Both variants are part of Stevanato Group's broader Alina^® variable-dose pen injector platform, which offers multiple pre-configured variants for GLP-1s and other injectable therapies.

Alina^® features a dial-a-dose mechanism with visual, audible, and tactile feedback during dose selection and injection, and compatibility with ISO standard 3 mL glass cartridges. The platform has been designed to support manufacturing scalability, and integration into existing pharmaceutical fill and finish and final assembly supply chains.

“We are pleased to see Alina^® incorporated into liraglutide-based therapies that have received marketing authorizations in multiple European markets,” said Michele Monico, President of Drug Delivery Systems & In Vitro Diagnostics at Stevanato Group. “This achievement highlights our commitment to support customers throughout their product journey, from development to commercialization. As demand for treatments addressing diabetes and weight management continues to grow, we are proud to provide drug delivery solutions that help enable broader patient access to these therapies.”

These authorizations come at a time when injectable therapies are playing an increasingly important role in healthcare, driven by the ongoing expansion of GLP-1 treatments and the broader shift towards patient-centric models of care and self-administration. Through its proprietary device portfolio – including Alina^® (variable-dose, pen injector), Deora™ (fixed-dose, pen injector), Aidaptus^® (autoinjector) and Vertiva^® (on-body delivery system) – Stevanato Group is expanding its drug delivery capabilities to support pharmaceutical and biotechnology companies developing next-generation therapies. Alina^® is manufactured within Stevanato Group's Drug Delivery Systems operations and leverages the Company's integrated expertise across pharmaceutical glass containers, engineering technologies, analytical services and device manufacturing. The platform has been designed to offer pharmaceutical partners a flexible and production-ready solution capable of supporting commercial-scale deployment.

“Drug delivery systems are playing an increasingly strategic role in the success of injectable therapies,” Monico added. “The rapid growth of biologics, GLP-1 therapies, and self-administration is reshaping how pharmaceutical companies approach product development and commercialization. As a result, demand is increasing for integrated solutions that combine device innovation, manufacturing expertise, and supply chain reliability. We believe our broad portfolio of drug delivery platforms, supported by our end-to-end capabilities, positions Stevanato Group well to support this evolution.”

About Alina^®

Alina^® is a variable-dose, disposable pen injector platform designed for subcutaneous drug delivery. The platform can accommodate doses from 0.01 mL up to 0.75 mL and includes multiple pre-configured variants developed for GLP-1 and other injectable therapies. Alina^® combines familiar handling, enhanced dose readability and flexible customization options to support a wide range of therapeutic requirements. For more information: Alina^® Variable Pen Injector Platform.

About Stevanato Group

Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients. To learn more, visit: www.stevanatogroup.com.

Forward-Looking Statements

This press release may include forward-looking statements. The words “believe,” “continues,” “to grow,” “increasing,” “to support,” “positions,” “scale,” “deployment,” “ongoing,” “expanding,” “increasingly,” “growth” and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the investments the Company expects to receive, the expansion of manufacturing capacity, the Company’s plans regarding its presence in the U.S. market, business strategies, the Company’s capacity to meet future market demands and support preparedness for future public health emergencies, and results of operations. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. In particular, the Company may determine not to conduct a registered initial public offering in the time frame that it currently expects or at all, due to a number of potential important factors, including conditions in the U.S. capital markets, negative global economic conditions, potential negative developments in the Company’s business, or unfavorable or regulatory developments. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260730802297/en/

Investor Relations
Lisa Miles: lisa.miles@stevanatogroup.com
Giacomo Guiducci: giacomo.guiducci@stevanatogroup.com

Media
Caterina Tripepi: caterina.tripepi@stevanatogroup.com
Stefania Bassi: s.bassi@barabino.it (Italy)
Marco Lastrico: m.lastrico@barabinousa.com (U.S.)

Source: Stevanato Group S.p.A.