Biosimilars

Positive phase III results for Hisun’s adalimumab copy biological

Biosimilars/Research | Posted 10/04/2020

Positive results were reported from a phase III trial of an adalimumab copy biological, HS016, which compared the candidate adalimumab copy biological HS016 with originator adalimumab Humira for the treatment of active ankylosing spondylitis (AS) [1].

Biosimilars and the safe harbor provision

Biosimilars/General | Posted 10/04/2020

In the US, the safe harbor provision exempts drug development and approval from patent infringement provisions, and courts have interpreted the safe harbor to apply broadly to Food and Drug Administration (FDA) regulated and approved products, including biologicals. However, courts have continued to struggle with the application of the safe harbor to different types of FDA submissions as the regulatory process has become more complex – and largely have continued to expand its scope.

EMA recommends approval of etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/04/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 March 2020 that it had recommended granting of marketing authorization for a biosimilar etanercept product.

Access to biosimilars in China, the EU and the US

Biosimilars/General | Posted 03/04/2020

Access to more affordable treatments is the main driver for the approval of biosimilars. But how does this accessibility vary between Europe, the US and China?

Clinical trials supporting the approval of adalimumab biosimilars

Biosimilars/Research | Posted 03/04/2020

Authors from Argentina and the UK critically review the evidence from trials of biosimilars in rheumatoid arthritis (RA) [1].

The Patients Association publishes new advice on switching to biosimilars

Biosimilars/General | Posted 03/04/2020

Patient advocacy group in the UK, The Patients Association, has published new information and an animated video about switching to biosimilars.

Use of anti-TNF biosimilars in the US

Biosimilars/Research | Posted 03/04/2020

Uptake of biosimilars in the US is slow to say the least. In fact, biosimilars currently make up only 2.3% of the US biologicals marketplace [1]. Researchers from the US therefore investigated whether anti-tumour necrosis factor (anti-TNF) biosimilars are realizing their promise to increase competition and improve accessibility in the US [2].