Non-biological complex drugs
Non-biological complex drugs (NBCD) are drugs with a complex structure that can not be produced by biotechnology, so no "biologics" (biologicals) are.
properties
Unlike small, chemically defined molecules ( small molecules , SM), NBCDs do not have a uniform molecular structure, but consist of many structurally very similar components and some have nanoparticulate properties. The product properties depend heavily on the manufacturing process.
Examples
The NBCD include, for example:
- Iron-carbohydrate complexes
- Glatiramoids
- Liposomal or micellar packaged substances
- Low molecular weight heparins
meaning
The molecular composition of the NCBDs is difficult to characterize because of the complexity of the material. Their uniform, reproducible quality is essentially due to the special manufacturing process ("The process is the product."). It is therefore difficult to compare NBCDs from different production processes. The clinical significance (efficacy, safety) of possible differences is not fully known.
The comparability of NBCDs is important both for the regulatory procedure for the approval of generic drugs and for the therapeutic interchangeability of NBCD drugs from different manufacturers. An identical composition of imitation products that are manufactured in a separate process cannot be proven, so that they can only be classified as similar to active ingredients.
The European Medicines Agency (EMA) and the US FDA have drafted various position papers and guidelines for the pharmaceutical industry on some NBCDs.
Low molecular weight heparins are already regulatory due to its biological origin in the EU and Biologicals treated.
swell
- DPhG , House of Pharma & Healthcare: Statement on the interchangeability of drugs with complex active ingredients , Pharmazeutische Zeitung, issue 41/2016.
- Daan JA Crommelin: Challenges for "Non-Biological Complex Drugs (NBCDs) , at a public hearing at the FDA in Silver Spring on May 16, 2014.
Individual evidence
- ↑ EMA / CHMP / SWP / 100094/2011 - Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications. . Retrieved August 15, 2017.
- ↑ EMA CHMP / SWP / 620008/2012 - Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product. . Retrieved August 15, 2017.
- ↑ FDA Draft guidance on Iron Sucrose, Recommended Mar 2012; Revised Nov 2013 . Retrieved August 15, 2017.
- ↑ FDA Draft Guidance on Iron Dextran, Recommended Oct 2016 . Retrieved August 15, 2017.