Fármacos complejos no biológicos

Glatiramoid follow-on NBCDs

Fármacos complejos no biológicos/Informes | Posted 11/03/2016

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].

FDA includes follow-on versions in its new liposome guideline

Fármacos complejos no biológicos/Directrices | Posted 26/02/2016

On 29 October 2015, the US Food and Drug Administration (FDA) issued a new draft guidance document for non-biological complex drugs (NBCDs). The new draft guidance on liposome drug products replaces draft guidance published in August 2002.

EU guidelines for follow-on NBCDs

Fármacos complejos no biológicos/Directrices | Posted 22/01/2016

Last update: 22 January 2016

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

GDUFA regulatory priorities for 2016 include complex drugs

Fármacos complejos no biológicos/Políticas y legislación | Posted 11/12/2015

As part of the Generic Drug User Fee Amendments (GDUFA) of 2012, the US Food and Drug Administration (FDA) committed to prepare a yearly list of regulatory science priorities for generics based on input from industry and other stakeholders.

Liposomal follow-on NBCDs

Fármacos complejos no biológicos/Informes | Posted 11/12/2015

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

Fármacos complejos no biológicos/Informes | Posted 13/11/2015

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

Fármacos complejos no biológicos/Informes | Posted 05/11/2015

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]. 

Follow-on glatiramer acetate (M356) claimed as equivalent to Copaxone

Fármacos complejos no biológicos/Investigación | Posted 05/11/2015

A multi-dimensional evaluation of the equivalence of a follow-on glatiramer acetate (M356) and the brand-name originator version (Copaxone) has been reported to show equivalence of biological and physicochemical properties, with no significant differences in the structure and function of the two products [1].

EMA issues reflection paper for follow-on versions of iron-based nano-colloidal products

Fármacos complejos no biológicos/Directrices | Posted 05/11/2015

On 27 March 2015, the European Medicines Agency (EMA) published its reflection paper for follow-on versions of iron-based nano-colloidal products. The agency first released the draft reflection paper for follow-on versions of iron-based nano-colloidal products for a three-month consultation period in September 2013.

FDA approves first follow-on version of glatiramer acetate

Fármacos complejos no biológicos/ Novedades | Posted 05/11/2015

The US Food and Drug Administration (FDA) announced on 16 April 2015 the approval of the first follow-on version of glatiramer acetate injection used to treat patients with relapsing forms of multiple sclerosis (MS).