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Biosimilars in the European Union Reports | Posted 10/11/2017

Dr Elena Wolff-Holz gave a keynote address at Medicines for Europe’s 15th Biosimilar Medicines Conference: Biosimilar Medicines: A game changer for healthcare sustainability [1].

Physicians urge CMS to adopt unique billing codes for biosimilars Policies & Legislation | Posted 10/11/2017

On 11 September 2017, groups representing physicians in the US commented on the biosimilar reimbursement policy of the Centers for Medicare & Medicaid Services (CMS). The six groups, which repr...

Mergers could be causing price increases for generics Generics/Research | Posted 10/11/2017

How mergers and acquisitions in the generics sector can be a factor in drug shortages and increasing prices was a question addressed by researchers from Carleton and McGill Universities in Canada [1].

Phase III switching data support long-term efficacy and safety of rituximab biosimilar Truxima Biosimilars/Research | Posted 10/11/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) rituximab biosimilar (Truxima, CT-P10) is comparable to Roche’s MabThera/Rituxan, according to the South Ko...

India updates its similar biologics guideline Guidelines | Posted 10/11/2017

The Indian Ministry of Health has revised its guidelines for approving ‘similar biologics’. The guideline was updated in order to make the regulatory pathway more robust and to align the guidelines...

EMA approval for tacrolimus generic Generics/News | Posted 10/11/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 12 October 2017 that it had recommended granting marketing authorization for the tacrolimus...

Humira deal could cost CMS US$1.48 billion Biosimilars/News | Posted 10/11/2017

The settlement deal made between US-based biotech giant Amgen and pharma giant AbbVie regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab) could cost the US Centers of Medicare and Med...

Physicochemical and biological characterization study of copy biological tocilizumab Biosimilars/Research | Posted 10/11/2017

Researchers in China have developed a copy biological of F. Hoffmann-La Roche’s  (Roche) arthritis treatment Actemra (tocilizumab). A recent study compares it to the originator, finding it to...