Guide to Biosimilars
- Published on Sunday, 25 January 2015 09:56
- Written by Administrator
A Health-System Pharmacist’s Guide to Biosimilars: Regulatory, Scientific, and Practical Considerations
To improve the affordability of popular but costly biological therapies, an abbreviated pathway for approval by the Food and Drug Administration (FDA) has been established for biological products that are “highly similar” (biosimilar) to or interchangeable with the innovator biological product. Biosimilars are not completely identical to the innovator product because of the large molecular size, complexity and proprietary nature of the manufacturing process, and inherent variability of all biopharmaceuticals.