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A blueprint for biosimilar assessment without efficacy trials Biosimilars/Research | Posted 13/11/2020

Comparative efficacy trials have played an important role in biosimilarity assessments. However, with recent technological advances, their role is now being questioned. Research published in Drug D...

Pharmacokinetics and generic drug switching: a regulators view Generics/Research | Posted 13/11/2020

Researchers from the Netherlands share their view on the pharmacokinetic aspects of generic drug switching, from a regulatory perspective. They argue that there is no reason to change the current a...

Biosimilar advances for Celltrion Healthcare Biosimilars/General | Posted 13/11/2020

South Korea-based biotechnology company Celltrion Healthcare announced advances related to their infliximab, omalizumab and adalimumab biosimilars.

AffaMed and EverInsight merger announced Pharma News | Posted 13/11/2020

AffaMed Therapeutics announced a merger agreement with EverInsight Therapeutics on 10 October 2020.  

EMA recommends approval of Lenalidomide Mylan Generics/News | Posted 13/11/2020

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 October 2020 that it recommends granting marketing authorization for the generic medicine...

Copy biological approvals in China, compared to the US and EU Biosimilars/Research | Posted 13/11/2020

A review of copy biological approvals in China finds that 75% of approved monoclonal antibodies, fusion proteins and granulocyte colony-stimulating factor (G-CSF) copy biologicals have be...

GBMA publishes information resources on biosimilars for consumers and carers Biosimilars/General | Posted 13/11/2020

The Generic and Biosimilar Medicines Association (GBMA), the representative body of generic and biosimilar medicine suppliers in Australia, has recently published information resources for consumer...

COVID-19 vaccine progress and FDA approvals for Zydus Cadila Generics/News | Posted 13/11/2020

India-based generics company, Zydus Cadila, has had many advancements with product development and approval between August and October 2020. In August, the company announced that its plasmid DNA va...