A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product Only minor differences in clinically inactive components are allowable in biosimilar products.
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~ Biologics
Biologics are developed using a complex process, as they are made by or extracted from living organisms, tissues, or cells These medicines have revolutionized the treatment and prevention of many, disabling and life threatening diseases in areas such as endocrinology, oncology, immunology, ophthalmology and dermatology.
However, as developing and supplying these medicines is complex, biologics are driving the rising cost of healthcare, and this may restrict patient access to potentially life saving treatments.
A biosimilar is a successor to a biologic product (also known as ‘reference product’) and it has the potential to improve access for patients, contribute to healthcare systems sustainability, increase treatment options for healthcare professionals and stimulate innovation in development of next generation biologics.
In the era of next generation biotechnology, Kashiv leverage its expertise and skill set especially in the areas of Biosimilars and Bio betters wherein we are equipped to handle Monoclonal Antibodies (Mabs), Fusion proteins, Enzymes, Antibody Drug Conjugates(ADCs), Hormones etc.
Biosimilars Reports
Biologics Reports
Kashiv BioSciences - Evolving Biosimilars Landscape
With rising US adoption, Biosimilars to continue rapid growth over the next decade.
Biosimilars continue to post monumental growth. Among recent biosimilar launches, bevacizumab, trastuzumab, and rituximab are set to reach nearly 60% share of volume for their respective molecules by the end of their second year on the market — showing significantly higher and faster uptake than prior biosimilars. This reflects efforts by providers to capture available savings, although their adoption has been highly heterogenous, while patients have benefitted from biosimilars in the form of lower out-of-pocket costs.
According to IQVIA’s Forecast Link, biosimilar value grew at a CAGR of 78% between 2015 and 2020, reaching approximately $17.9 bn in 2020 and is expected to continue growing at a CAGR of 15% between 2020 and 2030 reaching an estimated $75 bn within the next decade.
The pipeline of biosimilar development is more active than ever. More than 90 biosimilars are currently under development, including several biologics in new therapeutic classes, such as ophthalmology, bone health and immunosuppressants. In 2021, the first two biosimilars attained interchangeable status, which may facilitate the uptake of these molecules. In the coming years, more biosimilars are likely to attain this status.
Biosimilars continue to post monumental growth. Among recent biosimilar launches, bevacizumab, trastuzumab, and rituximab are set to reach nearly 60% share of volume for their respective molecules by the end of their second year on the market — showing significantly higher and faster uptake than prior biosimilars. This reflects efforts by providers to capture available savings, although their adoption has been highly heterogenous, while patients have benefitted from biosimilars in the form of lower out-of-pocket costs.
According to IQVIA’s Forecast Link, biosimilar value grew at a CAGR of 78% between 2015 and 2020, reaching approximately $17.9 bn in 2020 and is expected to continue growing at a CAGR of 15% between 2020 and 2030 reaching an estimated $75 bn within the next decade.
The pipeline of biosimilar development is more active than ever. More than 90 biosimilars are currently under development, including several biologics in new therapeutic classes, such as ophthalmology, bone health and immunosuppressants. In 2021, the first two biosimilars attained interchangeable status, which may facilitate the uptake of these molecules. In the coming years, more biosimilars are likely to attain this status.
Kashiv’s Strength- Clone to Commercial Mfg.
- State of the art R&D Facility at US & India
- Clone to commercial product development
- Capability to develop mammalian & microbial products like Mabs, Fusion Proteins, Vaccines, Enzymes, Cytokines
- Inhouse manufacturing capabilities
- Specially designed Bioreactors & Purification area
- Highly equipped analytical lab for biologics characterization
- Advanced Bioassay Lab
- Quality and Regulatory compliance system
- Qualified equipment & utilities
- Highly skilled technical professionals
- Pharmacology & Toxicology skillset
- Expert biologics IP team
What is a biosimilar?
Biosimilar Development
When considering licensure of a biosimilar product, FDA reviews the totality of the data and information, including the foundation of detailed analytical (structural and functional) characterization, animal studies if necessary, then moving on to clinical pharmacology studies and, as needed, other comparative clinical studies.