Non‐Biological Complex Drugs/
News
FDA approves 40 mg follow-on version of glatiramer acetate
Sandoz, the generics division of Novartis, announced on 13 February 2018 the approval of its 40 mg follow-on version of glatiramer acetate by the US Food and Drug Administration (FDA).
Mylan launches first follow-on glatiramer acetate in the UK
US generics giant Mylan announced on 23 January 2018 that it had launched Brabio, the first follow-on version of Teva Pharmaceutical’s (Teva) Copaxone (glatiramer acetate) in the UK.
Impax announces FDA approval of follow-on sevelamer carbonate
US generics maker Impax Laboratories (Impax) announced on 23 October 2017 that it had received final US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for a follow-on version of Renvela (sevelamer carbonate).
FDA approves follow-on version of sevelamer
Indian generics maker Aurobindo Pharma (Aurobindo) announced on 15 June 2017 that it had received US Food and Drug Administration (FDA) approval for its follow-on version of sevelamer.
Warning letter causes delays for follow-on glatiramer acetate
US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 17 February 2017 that Sandoz’s contracted fill/finish manufacturing partner, Pfizer, had received a US Food and Drug Administration (FDA) warning letter.
Follow-on versions of glatiramer acetate in Russia and Europe
US generics company Alvogen announced in September 2016 that it had launched a follow-on version of glatiramer acetate in Central and Eastern Europe. Then in November 2016, Russia’s Biocad announced that it had completed registration for its follow-on glatiramer acetate product in Russia.
Cancer lab to evaluate bioequivalence of nanosimilars
The Frederick National Laboratory for Cancer Research (Frederick National Lab) announced on 10 June 2016 that it was collaborating with the US Food and Drug Administration (FDA) on the characterization of nanosimilars.
A conference on ‘Equivalence of Complex Drug Products: Scientific and Regulatory Challenges’
A conference presented by the Non-Biological Complex Drugs Working Group (NBCD WG), the Nanotechnology Characterization Laboratory (NCL) of the Frederick National Lab for Cancer Research, and the New York Academy of Sciences on ‘the Equivalence of Complex Drug Products: Scientific and Regulatory Challenge’, Wednesday, 9 November 2016, from 8:30 am to 5:15 pm in New York, USA.
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.
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.
