Kashiv BioSciences is dedicated to responding to the global demand for increased access to biologic treatments.
Our high-quality biosimilars have the potential to reduce costs, increase accessibility, and provide patients with more options.
The Benefit of Biosimilars
Biologic medicines offer important treatment options for life-threatening and disabling diseases. Biosimilars are biologic medicines that have been deemed to be highly similar in quality, safety, and effectiveness to an existing biologic reference product. No clinically meaningful differences exist between the biosimilar and the original product. By introducing competition into the biologic market where there are few low-cost alternatives, biosimilars can contribute to increased, more affordable options for patients.1
Increased patient access
The introduction of biosimilars in Europe has resulted in the increased use of biologic drugs in the EU by as much as 100%.2 We anticipate increased usage in the U.S. as more biosimilars become commercially available.
Potential cost savings
Biosimilars are priced at substantial discounts versus the innovator biologic products and are expected to provide cost savings of up to $150 billion in the U.S. alone by 2026.3,4
Kashiv’s scientific expertise, systematic analytical approach, and robust infrastructure has led to the successful development and manufacturing of its two lead biosimilar candidates. Below is an overview of the biosimilar development and approval process.
Characterization of the Reference Biologic
Using state-of-the-art technology, the reference biologic product’s physiochemical and immunochemical properties, biological activity, and impurities are analyzed to define the critical quality attributes (CQAs) for biosimilar development.
Cell line development
Genetically engineered cell lines that produce the target proteins are developed by incorporating the DNA of the desired target molecule into the host cell line. Thousands of cell lines (clones) are screened and refined to select the lead biosimilar candidate with the desired CQAs.
Extensive studies utilizing robust analytical methods are conducted to show that no clinically meaningful differences exist between the proposed biosimilar and the reference product.
The cell culture conditions are refined to maximize yield and minimize impurities.
A clinical trial is conducted to test safety, efficacy, and immunogenicity to confirm clinical similarity.
Regulatory approval process
Sponsors work with regulatory bodies, such as the FDA and EMA, in a multi-tier approach to demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product.
Scale-up and Manufacturing
Kashiv is committed to achieving the highest level of quality and our commercial scale biosimilar manufacturing facilities are compliant with current good manufacturing practices (cGMPs).
1 “Biosimilars: More Treatment Options Are on the Way,” FDA Consumer Health Information, 2016.
2 “Delivering on the Potential of Biosimilar Medicines,” IMS Institute, 2016.
3 “Biosimilars: Infancy to Youth – Outlook Through 2025,” Morgan Stanley Research Global Insight, 2019.
4 “Biosimilar Cost Savings in the United States: Initial Experience and Future Potential,” Rand Health Quarterly, 2018.