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mRNA LNPs Drive Safe, Effective Repeat Dosing In Disease ModelsWell-designed lipid nanoparticles enable safe, efficient delivery. OVA-based models show how formulation choices shape efficacy, safety, and anti-tumor outcomes in melanoma research.
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ABOUT BIOSIMILAR MANUFACTURING
Biosimilars are considered to be low-cost substitutions for pricy, large-molecule biologics. However, biosimilars must meet the same quality, safety, and efficacy as their reference biologic. Manufacturing biosimilars requires a more complicated procedure than that of manufacturing small molecule generics. Companies manufacturing biosimilars are focused on creating a chemical structure that is as close as possible to that of the reference product. Failure rates and operational costs pose a challenge for those companies involved in manufacturing biosimilars compared to those manufacturing small molecule generics.
Small molecule generics are created using the same active pharmaceutical ingredient (API) and, therefore, are chemically identical to that of the originator medicine. The manufacturing process for small molecules comprises only one-fifth of the total in-process tests required to meet Good Manufacturing Practice compared to that of biologic medicines (50 vs. 250 in-process tests). In fact, the manufacturing process for a large molecule is so complex, it cannot be duplicated by two different manufacturers, as the cells used in biologic medicines are unique to the company manufacturing each biologic.
Manufacturing a biologic consists of genetically modifying a cell, which becomes the basis for a cell line used for the production of the necessary protein for the biologic medicine. The protein is then separated from the cells and purified. Biosimilars are created from small alterations to the manufacturing process which creates a molecule that is not identical but closely resembles the reference product. While the differences in the biosimilar molecule might be slight, these changes in the manufacturing process of a biosimilar can affect the efficacy and safety of a biosimilar compared to the reference biologic. Over the past decade, the manufacturing process for proteins has become more standardized and the required technology has become increasingly accessible, leading to reductions in biosimilars production costs. As a result, a greater number of companies have begun manufacturing biosimilars, while reference brand manufacturers are setting their sights on bolstering pipelines and manufacturing biobetters to maintain market share for their soon-to-be-off-patent reference products.
BIOSIMILAR DEVELOPMENT NEWS
- Organon Canada And Henlius Expand Access To Denosumab Treatments With Launch Of BILDYOS (denosumab injection) And TUZEMTY (denosumab injection), Biosimilars To PROLIA And XGEVA
- Sandoz To Host Capital Markets Day: Maximising Sandoz Value In Its Golden Decade For Biosimilars
- Organon And Samsung Bioepis Expand Agreement To Commercialize PYZCHIVA (ustekinumab), A Biosimilar Referencing STELARA (ustekinumab) In Canada
- AAM Applauds Momentum As Two Bills Move Through Senate HELP Committee
- Sandoz Steps Up In-House Biosimilar Capabilities, Opening State-Of-The-Art Development Centre To Capture 'Golden Decade' Opportunity