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Biosimilars applications under review by EMA – July 2020 Biosimilars/General | Posted 10/07/2020

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval...

Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym Biosimilars/News | Posted 10/07/2020

Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.

COVID-19 drug trials underway Pharma News | Posted 10/07/2020

There are over 200 trials for COVID-19 currently in progress. These include trials of monoclonal antibodies, including from the South Korean firm Celltrion, as well as vaccines, notably from the Ch...

Denmark achieves 83% reduction in adalimumab costs through switching Biosimilars/Research | Posted 10/07/2020

Spending on adalimumab in Denmark decreased by almost 83% between September and December 2018, thanks to a mandatory switching policy.

The cost of biologicals in Canada Reports | Posted 10/07/2020

The top 10 selling originator biological drugs accounted for over half of all biological sales in Canada in 2018, new data reveals.

Revance and Mylan move forward with Botox biosimilar Biosimilars/News | Posted 10/07/2020

US firm Revance Therapeutics (Revance) announced on 1 June 2020 that its partner, US-based drugmaker Mylan, had decided to move forward with a development plan, under a 351(k) pathway, for a propos...

EMA and FDA agree new priorities, including research on COVID-19 Policies & Legislation | Posted 10/07/2020

At the 2020 bilateral regulatory dialogue meeting, senior officials from the European Commission, European Medicines Agency (EMA) and US Food and Drug Administration (FDA) identified new strategic...

Cost-effectiveness of generic dabigatran Generics/Research | Posted 10/07/2020

Since the enactment of Hatch-Waxman Act in 1984, use of generics has grown substantially in the US. Generics now account for nearly nine out of 10 prescriptions and are considered a cost-containmen...