Biosimilar Sciences India LLP
Biosimilar Sciences India LLP is a subsidiary of Biosimilar Sciences PR LLC & Biosimilar Solutions. Biosimilar Solutions is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets.
Our Servies
Biosimilar helps you save money while advancing your pipeline
WHAT IS A BIOSIMILAR?
A biosimilar medicine is a biologic that is approved based on a demonstration that it..
Totality of Evidence
A biosimilar is approved by the FDA based on head-to-head comparisons of the biosimilar.
Stepwise Approach
Biosimilars are approved using data obtained in a stepwise fashion. The data are evaluated..
Critical Quality Attributes
Based on the many years of study of the reference product, along with comprehensive public information, biosimilar manufacturers
Biosimilarity
Biosimilarity is established when the totality of evidence supporting a biosimilar is assembled through analysis of all public information
Extrapolation
Extrapolation is the approval of a biosimilar for one or more conditions of use (known as “indications and usage”) for which its reference biological...
Solving the Start-up Paradox Go fast with Minimal Spending
Biosimilar helps you save money while advancing your pipeline
Biosimilars regulatory pathway
- The U.S. Regulatory Pathway for Biosimilars
- 351(k) Application Pathway Requirements
- Biosimilars Approvals
- The biological product is biosimilar to a reference product
Our Model
Biosimilar helps you save money while advancing your pipeline
Shared Resources To Lower Overall Cost
Side By Side Technical Transfer To Protect Your Ip
Full Control Of Your Space And Schedule
“Bio” Support You On Maximizing Grants And Credits
Societal Benefits Of Biosimilars
Biosimilar helps you save money while advancing your pipeline
Societal Benefits Of Biosimilars
The introduction of biosimilars is anticipated to help lower the cost burden of biologics on the U.S. health care system, and may help expand access to biological medicines. Expiring patents for several biological medicines in the coming years will create an opportunity to develop biosimilars to these products.
Some of the most difficult diseases that afflict people in the U.S., such as cancer, anemia, inflammatory bowel disease, and autoimmune disorders such as multiple sclerosis, rheumatoid arthritis, psoriasis, and Crohn’s and other inflammatory bowel diseases, may be treated or managed with biologics.
