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Converting a promising innovator biologic or biosimilar molecule into a pharmaceutical product presents numerous new challenges. For example, biologic medicines are highly viscous and formulated at high concentrations, which makes them more prone to aggregation. In addition, they need to be handled, packaged, stored, and transported carefully.⁵⁶ These requirements are driving innovation in packaging and delivery device development as, increasingly, drug companies demand technologies that can protect and administer these high‐value medicines safely and conveniently.⁵⁷

Historically, all biologic drugs were freeze‐dried and packaged in glass vials and administered, after reconstitution, using glass syringes. While most biologics are still packaged and delivered using glass, a growing number of biologics (including biosimilars) are packaged in plastic vials and administered using plastic syringes.

Devices for biosimilar administration are essential in quality use of medicine (QUM) considerations for biosimilars as for all biologics⁵⁸; they may also have critical practical implications for patients. These devices, either prefilled syringes, pens, or pumps, are important for dosing accuracy and reproducibility as well as long‐term patient compliance and adherence. From a patient perspective, one would envisage that the device via which a biosimilar is administered must at least be able to match the innovator biologic's device for convenience and comfort. Inferior usability may also reduce treatment adherence and product uptake by patients. The design and user experience of the delivery device may also serve as a critical market differentiator between the innovator biologic and the biosimilar.