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Interchangeability is an obstacle to the use of biosimilars in the US Biosimilars/Research | Posted 27/04/2018

According to Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA, there are several factors that may account for the slow development of the marke...

Australia approves rituximab biosimilar Truxima Biosimilars/News | Posted 27/04/2018

South Korean biotechnology company Celltrion announced on 23 April 2018 that Australia’s regulatory body, the Therapeutic Goods Administration (TGA), has approved its rituximab biosimilar, Truxima...

Phase I study of biosimilar trastuzumab demonstrates equivalent pharmacokinetics to reference product Biosimilars/Research | Posted 27/04/2018

Trastuzumab, a recombinant humanized monoclonal antibody, acts against the tyrosine kinase human epidermal growth factor receptor 2 (HER2), which is overexpressed in up to 30% of breast cancers and...

Fujifilm to acquire cell culture media companies Pharma News | Posted 27/04/2018

Fujifilm is expanding its ability to develop and manufacture biologicals by acquiring a pair of cell culture media businesses owned by Japan-based JXTG Holdings for a combined US$800 million.

Oregon introduces pricing transparency bill Policies & Legislation | Posted 27/04/2018

The US State of Oregon has signed a new bill into law that requires drugmakers to provide data justifying price hikes.

EU report finds decline in pay-for-delay pharma deals Reports | Posted 27/04/2018

The European Commission (EC) published the 8th Report on Monitoring Patent Settlements. It covers the 107 pharmaceutical patent settlements concluded between originator and generic drug companies i...

Teva launches ulcerative colitis generic in the US Generics/News | Posted 27/04/2018

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 26 March 2018 that it had launched generic mesalamine delayed-release tablets (1.2 g) in the US.

Regulation of biologicals in Colombia Guidelines | Posted 20/04/2018

Since the introduction of Decree 1782 Colombia has been moving towards a new regulatory landscape for biologicals (productos bioterapéuticos) and similar biotherapeutic products (productos biotera...