More Articles

Long-term stability of trastuzumab biosimilar under various storage conditions Biosimilars/Research | Posted 08/02/2019

Trastuzumab (TTZ) is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2). In some cancers, including certain types of breast cancers and gastric cancers,...

EMA approval for adalimumab biosimilars Idacio and Kromeya Biosimilars/News | Posted 08/02/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2019 that it had recommended granting marketing authorization for the adalimumab...

Barriers and facilitators to biosimilar prescribing in the UK Biosimilars/Research | Posted 08/02/2019

At present, the rate of uptake of biosimilars is keenly debated among stakeholders in different healthcare specialties. Aladul et al. examined the perspectives on biosimilars among healthcare profe...

Australia’s PBAC recommends substitution of adalimumab biosimilars Biosimilars/News | Posted 08/02/2019

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the adalimumab biosimilars Amgevita and Hadlima ‘should be treated as equivalent’ to the brand-name biological Hum...

FDA to improve Orange Book: issues draft guidance on marketing status Guidelines | Posted 08/02/2019

The US Food and Drug Administration (FDA) wants to enhance the utility of the Orange Book to foster drug competition.

India tightens regulation on generics manufacturers Policies & Legislation | Posted 08/02/2019

The pharmaceutical industry in India ranks third in the world in terms of volume and is the largest provider of generic medicines globally. However, concerns over the quality of generics manufactur...

FDA approves Lupin’s generic clobazam and Dr Reddy's launches follow-on sevelamer carbonate Generics/News | Posted 08/02/2019

By end of 2018, Lupin Pharmaceuticals Inc received US Food and Drug Administration (FDA) approval for its clobazam oral suspension, 2.5 mg/mL, and Dr Reddy's Laboratories Ltd (Dr Reddy) launched it...

Fuji Pharma acquires stake in Alvotech Pharma News | Posted 08/02/2019

Iceland-based biopharmaceutical company Alvotech announced on 19 November 2018 that Japan-based Fuji Pharma was investing in the company.