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EMA recommends approval of Sanofi’s insulin aspart biosimilar Biosimilars/News | Posted 15/05/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 30 April 2020 that it had recommended granting of marketing authorization for an insulin asp...

Scientific evidence in development of trastuzumab biosimilar ABP 980 Biosimilars/Research | Posted 15/05/2020

ABP 980 (Kanjinti) is a biosimilar to trastuzumab reference product (RP) (Herceptin), a monoclonal antibody directed against human epidermal growth factor receptor 2 (HER2). A biosimilar is hi...

GBMA publishes quarterly review of biosimilar literature Reports | Posted 15/05/2020

The Generic and Biosimilar Medicines Association (GBMA), which is the representative body of generic and biosimilar medicine suppliers in Australia, has released its quarterly review of biosimilar...

China publishes draft guideline for trastuzumab copy biologicals Guidelines | Posted 15/05/2020

China’s Center for Drug Evaluation (CDE) has published yet more specific guidance for makers of copy biologicals in the country, this time for trastuzumab.

Biosimilar education gaps in oncology Biosimilars/Research | Posted 15/05/2020

A survey administered by the International Society of Oncology Pharmacy Practitioners (ISOPP) identifies key educational needs on biosimilars amongst its practitioners, including how to compare a b...

US FDA clears Biocon manufacturing sites in Malaysia and India Biosimilars/General | Posted 15/05/2020

There has been successful closure of US Food and Drug Administration (FDA) inspections at Biocon Biologics sites in Malaysia and India. Three manufacturing sites were issued FDA establishment inspe...

Australia’s regulatory body proposes transparency reforms Policies & Legislation | Posted 15/05/2020

Australia’s Therapeutic Goods Administration (TGA) has issued a number of proposed transparency reforms for feedback from industry stakeholders, including earlier notification of generics applicati...

Why does the US face high-priced generics and drug shortages? Generics/Research | Posted 15/05/2020

Healthcare budgets in the US are under strain and the cost of prescription drugs is a continuous concern. Generic drugs offer cheaper alternatives to brand-name products due to competition. However...