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Interchangeability and switching study designs for biosimilars Reports | Posted 05/01/2018

In an information guide for healthcare professionals jointly prepared by the European Medicines Agency (EMA) and the European Commission (EC), interchangeability refers to the possibility...

FDA approves trastuzumab biosimilar Ogivri Biosimilars/News | Posted 05/01/2018

On 1 December 2017, the US Food and Drug Administration (FDA) approved its first trastuzumab biosimilar.

Reimbursement for oncology biosimilars in the US Biosimilars/Research | Posted 05/01/2018

How reimbursement issues for biosimilars might affect US oncologists was a subject discussed by Dr Rena Conti, Associate Professor of Health Policy and Economics in the Department of Paediatrics at...

Roche sues Pfizer over Herceptin biosimilar Biosimilars/General | Posted 05/01/2018

Switzerland-based drug giant Roche has sued pharma giant Pfizer for patent infringement on its blockbuster breast cancer drug Herceptin (trastuzumab) in an attempt to block competition from Pfizer’...

Impact of follow-on biological products in the Brazilian health system Biosimilars/Research | Posted 05/01/2018

Cancer is an epidemic disease in the 21st century. However, despite consistent increases on its incidence worldwide, mortality rates have fallen, especially in developed countries [1, 2]. The victo...

Jan Aushadhi and affordability and accessibility of medicines in India Generics/Research | Posted 05/01/2018

The pharmaceutical industry in India ranks third in the world in terms of volume and 14th in terms of value. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, t...

J&J drops lawsuit against Samsung Bioepis over Remicade biosimilar Pharma News | Posted 05/01/2018

Healthcare giant Johnson & Johnson (J&J) has dropped its lawsuit against South Korean biosimilars maker Samsung Bioepis for infringing patents on the company’s blockbuster immunology drug R...

FDA guidance aims to encourage abuse-deterrent generic opioids Guidelines | Posted 05/01/2018

The US Food and Drug Administration (FDA) has issued new guidance intended to encourage generics makers to make abuse-deterrent formulations of opioids.