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Biosimilars and availability of reference products Biosimilars/Research | Posted 15/01/2021

A survey was carried out by the World Health Organization (WHO) in 2019‒2020 covering most current topics pertinent to biosimilars [1].

Biosimilars applications under review by EMA – January 2021 Biosimilars/News | Posted 15/01/2021

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...

EC approval for pegfilgrastim biosimilar Nyvepria Biosimilars/News | Posted 15/01/2021

The European Commission (EC) has granted marketing authorization for the pegfilgrastim biosimilar Nyvepria (PF-06881894), developed by US-based drugmaker Pfizer and its subsidiary Hospira.

Influence of local policy measures and practices on biosimilar/originator market dynamics in Germany Biosimilars/Research | Posted 15/01/2021

In Europe, the individual Member States are responsible for designing policies that regulate the market entry and use of pharmaceuticals. This decentralized approach has been found to contribute to...

US guidance on proprietary names Guidelines | Posted 15/01/2021

The US Food and Drug Administration (FDA) issued a guidance for industry on best practices in developing proprietary names for prescription drugs, in December 2020 [1].

Positive phase III results for sintilimab plus copy biological Byvasda Biosimilars/Research | Posted 15/01/2021

China-based drugmaker Innovent Biologics (Innovent) announced on 23 November 2020 positive results for its copy bevacizumab biological Byvasda (IBI-305) in combination with sintilimab.

Perspectives of prescribing practices in public health facilities in South Africa Generics/Research | Posted 15/01/2021

Rational medicines use (RMU) is the prescribing/dispensing of good quality medicines to meet individual patient’s clinical needs. Policymakers, managers and frontline providers play critical roles...

Celltrion: Takeda acquisitions and new plant development Pharma News | Posted 15/01/2021

Celltrion completed the acquisition of selected primary care assets from Takeda Pharmaceutical Company Limited in the Asia Pacific region in November 2020. In addition, the company announced it wil...