Biosimilars
Clinical data requirements for biosimilars in the EU
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 requirements for biosimilars in the European Union (EU).
FDA approves Pfenex’s follow-on teriparatide product
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).
Biocon/Mylan launch first insulin glargine biosimilar in Australia
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 Benefits Scheme (PBS).
FDA releases new patient guidance on biosimilars
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 number of commonly asked questions.
Adalimumab copy biological shown to be safe and effective
Chinese biopharmaceutical firm Innovent Biologics’ adalimumab copy biological has shown comparable safety and efficacy to the originator drug, Humira (adalimumab), in patients with ankylosing spondylitis.
Biosimilars applications reviewed in the EU
The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006, the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].
Three darbepoetin alfa biosimilars approved in Japan
Three pharmaceutical companies have announced approval of their anaemia treatments for sale on the Japanese market, while Mochida reveals it will sell the first teriparatide biosimilar in the country.
Novo Nordisk to launch biosimilar insulin in the US
Novo Nordisk has announced plans to launch biosimilar versions of its NovoLog and NovoLog Mix insulin products in the US in January 2020.
iBio and CC-Pharming collaborate for rituximab copy biological in China
Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 27 August 2019 that it will expand its collaboration with China-based CC-Pharming for a rituximab copy biological in China.
Switching from originator to biosimilar epoetins appears to be effective and safe
Switching between biological drugs during pharmacological treatment leads prescribers and patients to ask themselves the question: ‘Will it be safe?’. In particular, when switching from an originator to a biosimilar, the belief that this choice is shaped by economic reasons feeds suspicions and controversies.
