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Is a biosimilar forever or just for Christmas? Reports | Posted 24/11/2017

Dr Elena Wolff-Holz discussed the need for clinical studies and the evolution of biosimilars over time. During her keynote address at the biosimilar medicines conference in London, UK, Dr Wolf...

EMA approval for bevacizumab biosimilar Mvasi Biosimilars/News | Posted 24/11/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 10 November 2017 that it had recommended granting marketing authorization for the bevacizuma...

Switching to biosimilar infliximab in IBD patients Biosimilars/Research | Posted 24/11/2017

Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options, such as CT‑P13 (Remsima/Infl...

REMS issues come under FDA spotlight Generics/General | Posted 24/11/2017

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has once again chastised brand-name drug companies that deliberately delay federal procedures and use regulations to delay the e...

Perceptions and attitudes towards generics in South Korea Generics/Research | Posted 24/11/2017

A survey of the perception and attitude of South Korean physicians towards generics has shown that not much has changed despite the introduction of a new pharmaceutical policy in 2012 [1].

Biosimilars in oncology in the US Biosimilars/Research | Posted 24/11/2017

As part of the Affordable Care Act of 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allows for an abbreviated license pathway for the approval of biosimilars in the US...

FDA tentatively approves pemetrexed generic Generics/News | Posted 24/11/2017

Eagle Pharmaceuticals (Eagle) announced on 27 October 2017 that it had been granted tentative approval from the US Food and Drug Administration (FDA) for its generic version of Eli Lilly’s lung can...

FDA publishes new draft guidance for ADHD generic Guidelines | Posted 24/11/2017

In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.