News

FDA announces two actions to combat drug shortages

Published on 2014/04/01

The US Food and Drug Administration (FDA) announced on 31 October 2013 that it is taking two important actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages. ...

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Biosimilars: what patients need to know

Published on 2014/03/27

Biosimilars are medicines that are similar to a biological medicine that has already been authorized. Biosimilars are different to generics in that they are not identical to their reference produc...

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Calls for biosimilars to have same INN at WHO meeting

Published on 2014/03/25

The World Health Organization (WHO) held its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances on 22 October 2013 in Geneva, Switzerland. During the meet...

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Washington State legislation on biosimilars

Published on 2014/03/20

Biologicals manufacturers represented by the Biotechnology Industry Association (BIO) and the Washington Biotechnology & Biomedical Association have welcomed proposed Washington State legislation ...

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Top 10 most read GaBI Online articles in 2013

Published on 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 the hot topic of the year for Ga...

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Remsima approved in Colombia

Published on 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 Remsima (inflixima...

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Sandoz gains Danish approval for innovative asthma inhaler

Published on 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 deficit hyperactivity disorder (ADHD) drug Addera...

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Sandoz makes deal with Shire for authorized Adderall XR generic

Published on 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 deficit hyperactivity disorder (ADHD) drug Addera...

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Similar biotherapeutic products approved and marketed in Latin America

Published on 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 for biosimila...

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Extrapolation of biosimilar infliximab indications to inflammatory bowel disease

Published on 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 statements from various prof...

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EMA issues draft reflection paper for iron-based nano-colloidal products

Published on 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 products dev...

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Establishing mAb biosimilarity before reaching the clinic

Published on 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, The Neth...

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