Germany is for the first time to adopt national guidelines on prescribing biologics and biosimilars in move towards increasing biosimilar uptake.
Impending new guidelines on prescribing biologics advise German doctors to consider the economic case for prescribing a biosimilar instead of the reference product. The guidelines are a first step towards increasing usage of biosimilars in a bid to save costs.
The guidelines were mandated by the Act for Greater Security in the Pharmaceutical Supply System (GSAV), which was enacted in...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
