Non‐Biological Complex Drugs

Collaboration to introduce nanotechnologies in early stage drug development

The Frederick National Laboratory for Cancer Research (Frederick National Lab) announced on 10 June 2016 that it was collaborating with several major pharmaceutical companies. The collaboration aims to help them adopt nanotechnologies in early stage drug development, which, says the lab, is when the approach is most efficient and cost-effective.

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].

Rigorous approach used to approve a follow-on version of glatiramer acetate

Despite the difficulties associated with evaluating follow-on versions of non-biological complex drugs (NBCDs), the rigorous approach used by the US Food and Drug Administration (FDA) was able to establish the sameness of a follow-on glatiramer acetate (Glatopa) compared to Copaxone, according to researchers from Momenta Pharmaceuticals, the Northwestern University Feinberg School of Medicine and Kantor Neurology [1].

US guidelines for follow-on NBCDs

Last update: 1 June 2018

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Non-biological complex drugs and their follow-on versions

Since the first publication on non-biological complex drugs (NBCDs) appeared in 2011 this class of drug products has attracted growing interest and has resulted in the establishment of an Editorial Section on NBCDs in both the GaBI Journal and GaBI Online[1].

Is a new pathway for NBCDs on the way in the US?

The US Food and Drug Administration (FDA) does not formerly recognize non-biological complex drugs (NBCDs), with originators required to follow the new drug application (NDA) route and follow-on NBCDs using the generics – abbreviated new drug application (ANDA) – route [1].

Follow-on glatiramer acetate gains European approval

Netherlands-based biologicals company Synthon announced on 12 April 2016 that it had successfully concluded the decentralized procedures for its follow-on glatiramer acetate product.

FDA includes follow-on versions in its new cyclosporine guideline

In February 2016, the US Food and Drug Administration (FDA) issued a new draft guidance document for non-biological complex drugs (NBCDs). The new draft guidance on cyclosporine drug products replaces draft guidance published in March 2015.

Switching between originator and follow-on iron-sucrose

Researchers from France describe and compare the haematological parameters and anaemia medications used in chronic kidney disease (CKD) patients undergoing haemodialysis, before and after switching between the iron-sucrose originator and an iron-sucrose follow-on version [1].

Follow-on intravenous iron formulations in haemodialysis patients

A study into the efficiency of follow-on intravenous (IV) iron formulations compared to originator formulations in haemodialysis patients has shown the follow-on products to be less efficient at maintaining the same haemoglobin levels [1].