Biosimilars
ShilpaBio has first-in-class biosimilar products in development pipeline.
Biosimilars are attractive for their affordable costs and access enhancement to a wider patient population. The world has witnessed a growing need for biosimilars treatment and the market is expected to grow enormously in the next decade. ShilpaBio welcomes partnership opportunities to maximize the biosimilars reach to a diverse patient population across globe.
What are Biosimilars?
As the name suggests, Biosimilars signify the similarity to original biologic medicines providing the same quality, efficacy and safety evaluated by regulatory agencies
Relevancy to Patients
A patient treated with a reference product can change to its approved biosimilar, without loss of efficacy or an increase in safety risk along with an added benefit of costs savings
Information for Healthcare professionals(Doctors, Pharmacists, and Nurses)
Biosimilars offer promises to the healthcare professionals with,
1) More treatment options
2) More access to medications that can save lives
3) Possibility that market-competition will drive down the costs of healthcare
Biosimilars approval enables interchangeability of medicines in the hope of increased access to important and life-saving medications to the global patient population
ShilpaBio follows US-FDA’s Totality of Evidence Strategy for Biosimilars Development
List of Guidelines
Europe |
||
| Sr. No. | Guideline Name | Effective Date |
|---|---|---|
| 1 | Guideline on similar biological medicinal products | 23 October 2014 |
| 2 | Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues | 18 December 2014 |
| 3 | Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) | 22 May 2014 |
US |
||
| Sr. No. | Guideline Name | Effective Date |
| 1 | Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product | April 2015 |
| 2 | Scientific Considerations in Demonstrating Biosimilarity to a Reference Product | April 2015 |
| 3 | Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product | December 2016 |
| 4 | Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed | February 2020 (Draft guidance) |
| 5 | Considerations in Demonstrating Interchangeability With a Reference Product: Update | June 2024 (Draft guidance) |
India |
||
| Sr. No. | Guideline Name | Effective Date |
| 1 | GUIDELINES ON SIMILAR BIOLOGICS: Regulatory Requirements for Marketing Authorization in India, 2016 | 15th August 2016 |
| 2 | Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy | 10th April 2024 (Draft guidance) |
| 3 | Post Approval Changes in Biological Products: Quality Safety and Efficacy Documents | 16th May 2024 |
