I wonder something abouth processing and making biosimilar.
I understood if a biotecnological durg patent is done and if we make similar like it, its become biosimilar, is't it?
So, if I took a human insuline mrna to traslate to cdna and transform with good vector to a bacteri or even yeast or mammalian cell, after I produce insuline, so did I made biosimilar? ( I m wondering before tested them on human).
if not why?
what kind of things should be uniq
can you share with me an article or someting, how to make a hormone or anticore biosimilar or etc.
Thank you for your answers
Hi,
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-clinical-development-similar-biological-medicinal-products-containing_en-0.pdf
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
https://www.fda.gov/media/133014/download
Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
https://www.fda.gov/news-events/press-announcements/statement-efforts-help-make-development-biosimilar-and-interchangeable-insulin-products-more
Its key regulatory documents related to biosimilar insulin, hope could be helpful
Best regards
Tomasz
- Badges
- Science topic
- Similar topics
- Medicine
- Life Sciences
- Biotechnological Engineering