More Articles

Safety surveillance of bevacizumab biosimilar (Bevax) in Argentina Generics/Research | Posted 15/02/2019

Benefit-risk evaluations are mandatory throughout the life cycle of a therapeutic agent, to guarantee efficacy for the authorized indications without an unacceptable incidence of adverse effects. T...

PanGen gains Malaysian approval for epoetin alfa biosimilar Biosimilars/News | Posted 15/02/2019

South Korea-based biotechnology company PanGen Biotech (PanGen) announced on 7 February 2019 that Malaysia’s National Pharmaceutical Regulatory Agency has granted sales approval for Erisa, an epoet...

European regulatory framework for approval of biosimilars – perspectives and future developments Generics/Research | Posted 15/02/2019

Regulatory agencies around the world have reviewed and approved marketing authorization applications for biosimilars via specific marketing authorization procedures that vary between jurisdictions....

45 US states have passed biosimilar substitution laws Policies & Legislation | Posted 15/02/2019

Despite the fact that the US Food and Drug Administration (FDA) has yet to approve a biosimilar as interchangeable with its reference biological, many US states have been considering legislation on...

Samsung Bioepis makes deals for copy biologicals in China Pharma News | Posted 15/02/2019

Samsung Bioepis has made deals with two Chinese firms to expand its business in the country.

ICH proposes harmonization of standards for generics Guidelines | Posted 15/02/2019

As part of its efforts on harmonizing guidelines around the world the International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has released a ref...

Impact of generic reference pricing on candesartan and rosuvastatin use in South Africa Generics/Research | Posted 15/02/2019

Researchers from South Africa and The Netherlands investigated the effect that generics and generic reference pricing has on candesartan and rosuvastatin use in South Africa [1].

Zydus gets FDA approval for skin, heart and acid reflux generics Generics/News | Posted 15/02/2019

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market betamethasone dipropionate cream, 0.05%, a generic version of Diprolene® AF, and generic amlodipine...