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].