Home / Non‐Biological Complex Drugs / Reports
Reports
Equivalence of complex drug products
Complex drug products and their generic (or follow-on) versions was the subject discussed at the New York Academy of Sciences symposium on Equivalence of Complex Drug Products: Scientific and Regulatory Challenges [1].
Determining the bioequivalence of follow-on iron formulations
Challenges associated with determining the bioequivalence of follow-on iron formulations as non-biological complex drugs (NBCDs) was a subject discussed at the US Food and Drug Administration’s Public Meeting, which was held in June 2016, as part of the agency’s FY 2016 Regulatory Science Initiatives.
Challenges in the assessment of ophthalmic emulsions
Challenges in the assessment of the similarity or equivalence of ophthalmic emulsions as non-biological complex drugs (NBCDs) was a subject discussed at the US Food and Drug Administration’s (FDA) Public Meeting, which was held in June 2016, as part of the agency’s FY 2016 Regulatory Science Initiatives.
Iron carbohydrate follow-on NBCDs
Follow-on versions of iron–carbohydrate non-biological complex drugs (NBCDs) was a subject discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27-28 October 2014 [1].
Glatiramoid follow-on NBCDs
Follow-on versions of glatiramoid non-biological complex drugs (NBCDs) was a subject discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].
Liposomal follow-on NBCDs
Follow-on versions of liposomal non-biological complex drugs (NBCDs) was a subject discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].
Regulations for follow-on NBCDs
Regulations for follow-on versions of non-biological complex drugs (NBCDs) in Europe and the US were discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].
Status and regulatory issues surrounding follow-on NBCDs
Status and outstanding regulatory issues for follow-on versions of non-biological complex drugs (NBCDs) were discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].
Generics News Research General
- Safety surveillance of bevacizumab biosimilar (...Generics/Research | Posted 15/02/2019
- European regulatory framework for approval of b...Generics/Research | Posted 15/02/2019
- Impact of generic reference pricing on candesar...Generics/Research | Posted 15/02/2019
- Zydus gets FDA approval for skin, heart and aci...Generics/News | Posted 15/02/2019
Biosimilars News Research General
- PanGen gains Malaysian approval for epoetin alf...Biosimilars/News | Posted 15/02/2019
- Long-term stability of trastuzumab biosimilar u...Biosimilars/Research | Posted 08/02/2019
- Barriers and facilitators to biosimilar prescri...Biosimilars/Research | Posted 08/02/2019
- Liability chain of biosimilar switchingBiosimilars/Research | Posted 01/02/2019