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FDA releases 48 new and revised bioequivalence guidelines for generics Guidelines | Posted 21/08/2015

The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics contai...

Hikma to acquire Boehringer Ingelheim’s US generics business Pharma News | Posted 21/08/2015

Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) announced on 28 July 2015 that it had made a deal with Germany’s Boehringer Ingelheim to acquire the latter’s US generics business: Roxane Labor...

FAST generics act re-introduced to increase generics competition Policies & Legislation | Posted 21/08/2015

On 18 June 2015, US lawmakers Steve Stivers and Peter Welch re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generics, boost market competition a...

Overcoming hurdles to biosimilars cost savings in the US Biosimilars/Research | Posted 14/08/2015

The US approved its first biosimilar, Zarxio (filgrastim-sndz), on 6 March 2015 [1]. But how can the country overcome hurdles to the cost savings that can be achieved from these drugs? That is a qu...

Clinical programmes for anti-TNF biosimilars Reports | Posted 14/08/2015

Biosimilars for anti-tumour necrosis factor (anti-TNF) drugs are currently under development. These include biosimilars of blockbusters such as AbbVie’s Humira (adalimumab), Amgen’s Enbrel (etanerc...

Phase I results for candidate adalimumab, etanercept and infliximab biosimilars Biosimilars/Research | Posted 14/08/2015

Results of phase I clinical studies of candidate adalimumab biosimilar SB5, etanercept biosimilar SB4 and infliximab biosimilar SB2, demonstrated equivalence safety profiles to their originator bio...

Non-originator infliximab approved in Russia Biosimilars/News | Posted 14/08/2015

South Korean biotechnology company Celltrion announced that it had received approval for its non-originator infliximab, Remsima, from Russia’s Ministry of Health (Министерство здравоохранения Росси...

FDA wants generics to be physically same as originators Guidelines | Posted 14/08/2015

Until now generics have been required to be pharmaceutically equivalent and bioequivalent to the brand-name drug, however, generics made by different manufacturers could differ substantially from t...