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Guidelines for biosimilars around the world Reports | Posted 13/04/2018

Biosimilar guidelines and regulations are being developed all over the world, as outlined by Huiguo Hu at the Biosimilars Europe Congress [1].

EMA approval for infliximab biosimilar Zessly Biosimilars/News | Posted 13/04/2018

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 infliximab bi...

Three US states pass biosimilar substitution bills Policies & Legislation | Posted 13/04/2018

The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. To date, FDA has approved nine biosimilars and two follow-on biologicals [2]. All t...

EMA opens public consultation on GMP non-compliance template Guidelines | Posted 13/04/2018

The European Medicines Agency (EMA) announced on 3 April 2018 that it had opened a public consultation concerning the European Union (EU) template for good manufacturing practice (GMP) non-complian...

Strategies for development and validation of neutralizing antibody assays supporting biosimilars Biosimilars/Research | Posted 13/04/2018

A biosimilar is a biological product with equivalent safety, purity and potency as an originator reference therapeutic. As such, US Food and Drug Administration (FDA) and European Medicines Agency...

Australia’s Mayne Pharma launches generic antibiotic in US Generics/News | Posted 13/04/2018

Australia-based Mayne Pharma announced on 15 March 2018 that it had launched a generic version of doxycycline monohydrate immediate release (IR) capsules (50, 75 and 100 mg) in the US.

Stada resubmits biosimilar pegfilgrastim but stops adalimumab development Pharma News | Posted 13/04/2018

German generics giant Stada Arzneimittel (Stada) was informed on 2 March 2018 by Gedeon Richter (Richter) that the European Medicines Agency (EMA) has accepted the regulatory resubmission of its pr...

ACI 9th Annual Summit on Biosimilars 2018 Conferences | Posted 13/04/2018

ACI 9th Annual Summit on Biosimilars 2018 25−27 June 2018 InterContinental New York Times Square New York, NYUSA