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Clinical data requirements for biosimilars in the EU Biosimilars/Research | Posted 11/10/2019

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) discussed the clinical data require...

FDA approves Pfenex’s follow-on teriparatide product Biosimilars/News | Posted 11/10/2019

US-based biotech firm Pfenex announced on 7 October 2019 that it had received approval from the US Food and Drug Administration (FDA) for its follow-on teriparatide product (PF708).

EMA provides guidance on avoiding nitrosamines in human medicines Guidelines | Posted 11/10/2019

On 26 September 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided guidance on avoiding the presence of nitrosamine impurities in human medic...

Biocon/Mylan launch first insulin glargine biosimilar in Australia Biosimilars/News | Posted 11/10/2019

India-based biologicals specialist Biocon and US-based partner Mylan announced on 3 October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Ben...

FDA releases new patient guidance on biosimilars Biosimilars/General | Posted 11/10/2019

The US Food and Drug Administration (FDA) has released new patient materials on biosimilars, which explain that biosimilars are as safe and effective as their reference biological and answer a numb...

Adalimumab copy biological shown to be safe and effective Biosimilars/Research | Posted 11/10/2019

Chinese biopharmaceutical firm Innovent Biologics’ adalimumab copy biological has shown comparable safety and efficacy to the originator drug, Humira (adalimumab), in patients with ankylosing spond...

Strong generics nocebo effect found in US Generics/Research | Posted 11/10/2019

In the US, generic drug products account for approximately 90% of all prescriptions dispensed [1]. Despite this, there is a continued lack of trust in these drug products. Generics are often percei...

Alimta and Orfadin generics approved by FDA Generics/News | Posted 11/10/2019

The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cancer drug Alimta, and approved Novitium Pharma’s generic equivalent of Swed...