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Biosimilars for inflammatory bowel disease in Norway Biosimilars/Research | Posted 09/05/2014

Europe approved its first biosimilar monoclonal antibody Inflectra/Remsima (infliximab) on 10 September 2013 [1]. The biosimilar is now recommended by the Norwegian Drug Procurement Cooperation (LI...

Sandoz advances biosimilars pipeline Biosimilars/News | Posted 09/05/2014

Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 28 April 2014 that it had reached several important milestones in the development of biosimilar etanercept, filgrastim and peg...

Generics applications under review by EMA – April 2014 Generics/General | Posted 09/05/2014

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centrali...

Biosimilar trastuzumab candidates in phase III development Biosimilars/Research | Posted 09/05/2014

The introduction of Herceptin (trastuzumab) revolutionalized the treatment of breast cancer. Prior to its introduction there were few treatment options available to women with human epidermal growt...

The Brazilian generics market Reports | Posted 09/05/2014

Generics are an effective tool to provide affordable, safe and reliable medicines to patients in Brazil, according to a presentation by Telma Salles [1].

Iranian guidelines for ‘biogenerics’ Guidelines | Posted 09/05/2014

The regulatory body for approval of medicines in Iran is the Ministry of Health and Medical Education through its Food and Drug Organization (FDO). The agency is responsible for the scientific eval...

FDA sued over generic celecoxib approval Generics/News | Posted 09/05/2014

Generics makers Actavis and Mylan Pharmaceuticals (Mylan) have sued the US Food and Drug Administration (FDA) over the agency’s decision to award exclusive rights to Teva Pharmaceutical Industries...

Biosimilar merger for Epirus and collaboration for Catalent Biosimilars/News | Posted 09/05/2014

Mergers and collaborations are still in vogue in the biosimilars arena. The latest firms to announce deals are Epirus Biopharmaceuticals (Epirus), which will merge with Zalicus; and Catalent, which...