Biosimilars Development & Commercialization
BioTechLogic’s team of experts has broad experience working on the front lines of biosimilar development.
The biosimilars market only first began in the early 2000’s. Advancing analytical and characterization technologies, legislative and regulatory support within leading global markets, biosimilar development experience, and a second biologics patent cliff, have positioned the sector for growth.
Complete Biosimilars Product Lifecycle Support
BioTechLogic has extensive experience with biosimilar development and commercialization, from preclinical to market. Through more than 32 biosimilars projects, we have the experience and the expertise to help.
Biologics Characterization & Analytical Understanding
Understanding which critical quality attributes (CQAs) deliver the needed therapeutic performance and safety profiles is essential for a successful biosimilar program. Thorough product characterization and understanding, driven by strategic and effective analytical strategies, are essential.
How BioTechLogic Can Help
- Product characterization
- Analytical method development & strategies
- Critical Quality Attributes understanding
- Purification processes
- Upstream process development and scale-up
- Downstream process development & scale-up
- Regulatory filing support
- CDMO selection
Biosimilars CMC Services
Regulatory Consulting & Submissions Support
Process Development & Validation
Contract Services & Tech Transfer Support
Supply Chain Management
Years of Experience
A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product. Unlike generic small molecules, it is difficult to standardize such inherently complex products based on complicated...
As more biosimilars gain FDA approval for marketing in the United States, and more manufacturers launch programs to develop additional competitive biotech therapies, concerns have emerged that continued growth in this area could be limited by mounting pressure to push...