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Biosimilar policies in Europe Biosimilars/Research | Posted 06/04/2018

Across European countries, differences exist in biosimilar policies, e.g. pricing and reimbursement procedures, levels of education, characteristics of covered population and incentivization of sta...

EMA approval for trastuzumab biosimilar Kanjinti Biosimilars/News | Posted 06/04/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 March 2018 that it had recommended granting marketing authorization for the trastuzumab b...

FDA approach to retrospectively naming biologicals Reports | Posted 06/04/2018

How the US Food and Drug Administration’s (FDA) is tackling retrospective naming of biologicals was an issue covered by Dr Kellie Taylor, Associate Director of the Office of Medication Error Preven...

Etanercept biosimilar SB4 less immunogenic than Enbrel Biosimilars/Research | Posted 06/04/2018

A research letter published in the British Journal of Dermatology suggests that the biosimilar etanercept SB4 is less immunogenic than the originator product, Amgen/Pfizer’s Enbrel (etanercept) [1].

Portugal increases use of generics for treatment of cardiovascular diseases Generics/Research | Posted 06/04/2018

In Portugal, the use of medicines for cardiovascular system increased nearly two-fold between 2000 and 2010. As such, over a quarter of the overall expenditure on medicines during these years went...

NGO urges HIV drug patent application to be denied in Argentina Generics/General | Posted 06/04/2018

In March 2018, Argentine NGO, the Fundación Grupo Efecto Positivo (FGEP), requested that the country’s National Institute of Industrial Property (INPI) deny Gilead Sciences Inc’s patent request for...

FDA releases 52 new and revised bioequivalence guidelines for generic drugs Guidelines | Posted 06/04/2018

As part of its ongoing efforts to provide product-specific guidance for generics makers the US Food and Drug Administration (FDA) has again released several new and revised bioequivalence documents...

Korea’s CJ Healthcare shares biosimilar technology with China Pharma News | Posted 06/04/2018

South Korea’s CJ HealthCare, announced that it has signed a contract with China’s NCPC GeneTech Biotechnology on 31 January 2018 to export CJ-40001, a biosimilar version of darbepoetin alfa wh...