News
Top 10 most read GaBI Online articles in 2013
2014-03-18 2013 was a busy year with lots of developments in the biosimilars arena, ranging from revision of regulatory guidelines to new biosimilar approvals. Biosimilars remain… Read More »
Remsima approved in Colombia
2014-03-11 On 16 December 2013, Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos Y Alimentos) announced the approval of… Read More »
Sandoz gains Danish approval for innovative asthma inhaler
2014-03-06 Shire announced on 2 December 2013 that its subsidiary Shire US had entered into an agreement to supply an authorized generic version of its attention… Read More »
Sandoz makes deal with Shire for authorized Adderall XR generic
2014-02-20 Shire announced on 2 December 2013 that its subsidiary Shire US had entered into an agreement to supply an authorized generic version of its attention… Read More »
Similar biotherapeutic products approved and marketed in Latin America
2014-02-18 Last updated: 8 November 2013 Regulation of similar biotherapeutic products in Latin America varies widely among different countries and many countries have yet to introduce guidance… Read More »
Extrapolation of biosimilar infliximab indications to inflammatory bowel disease
2014-02-13 Gastroenterologists are wary of using biosimilars of infliximab in the treatment of inflammatory bowel disease. This fact is being evidenced by the publication of position… Read More »
EMA issues draft reflection paper for iron-based nano-colloidal products
2014-02-11 On 7 October 2013, the European Medicines Agency (EMA) announced the publication of a draft reflection paper‡ to discuss the data requirements for intravenous iron-based nano-colloidal… Read More »
Establishing mAb biosimilarity before reaching the clinic
2014-02-06 Confirming the biosimilarity of monoclonal antibodies (mAbs) is fraught with challenges beyond those faced by currently approved biosimilars, warn Ebbers and co-authors at Utrecht University,… Read More »
Transplant coordinators’ perception of generic immunosuppressants
2014-02-04 Transplant coordinators associate the availability of multiple generic immunosuppression therapies with increased patient confusion, according to a study by Parker and co-authors. Immunosuppression regimens containing… Read More »
More immunogenicity data needed for biosimilar mAbs
2014-01-30 Eight therapeutic monoclonal antibodies (mAbs) will lose EU and US patent protection before 2020, making way for a new class of biosimilar. The promise of… Read More »
