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FDA withdraws biosimilar statistical guidance Guidelines | Posted 06/07/2018

The US Food and Drug Administration (FDA) announced on 21 June 2018 that it had withdrawn the draft guidance on analytical studies of biosimilars. The agency does, however, plan to issue an amended...

Biosimilars applications under review by EMA – June 2018 Biosimilars/General | Posted 06/07/2018

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...

Biosimilarity testing using very low doses of rituximab Biosimilars/Research | Posted 06/07/2018

Rituximab is a chimeric, monoclonal antibody directed against CD20 expressed on B lymphocytes [1]. Currently approved indications for use are non-Hodgkin lymphomas, chronic lymphatic leukaemia, rhe...

FDA rejects botulinum toxin biosimilar from Evolus Biosimilars/News | Posted 06/07/2018

US-based Evolus announced on 16 May 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of DWP‑450 (prabotulinumtoxinA).

Analytical similarity for biosimilars Reports | Posted 06/07/2018

Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA), gave a presentation on demonstrating analytical similarity for biosimilars at the US Drug Information Associ...

China to extend drug patents and tackle anticompetitive behaviour Policies & Legislation | Posted 06/07/2018

According to reports, China is planning to increase patent protection on originator drugs to 25 years, increasing it by five years from the current patent protection period of 20 years. The country...

UK investigates price increases for generics Generics/General | Posted 06/07/2018

In light of recent increases in the price of generics, the UK’s National Audit Office (NAO) has carried out an investigation into the causes of the increases.

Pfenex makes biosimilar deals with Alvogen and NT Pharma Pharma News | Posted 06/07/2018

US-based biotech firm Pfenex has made commercialization deals for its candidate teriparatide biosimilar (PF708) in China and in the US.