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Samsung Bioepis expands biosimilars agreement with Biogen Pharma News | Posted 06/12/2019

Korean biosimilars giant Samsung Bioepis has extended its commercialization agreement with Biogen to include biosimilars to two ophthalmology drugs, Lucentis (ranibizumab) and Eylea (aflibercept)....

EMA recommends approval for two new generics Generics/News | Posted 06/12/2019

The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: clopidogrel/acetylsalicylic acid a...

FDA issues draft guidance for insulin biosimilars Guidelines | Posted 29/11/2019

The US Food and Drug Administration (FDA) announced on 25 November 2019 that it had issued draft guidance on immunogenicity considerations for insulin biosimilars.

EC approval for subcutaneous infliximab biosimilar Remsima SC Biosimilars/News | Posted 29/11/2019

South Korean biotechnology company Celltrion Healthcare (Celltrion) announced on 26 November 2019 that it had received European Commission (EC) approval for the subcutaneous (SC) formulation of its...

WHO launches insulin prequalification programme Biosimilars/General | Posted 29/11/2019

The World Health Organization (WHO) has announced a pilot prequalification scheme to certify biosimilar versions of insulin in order to increase supply in low- and middle-income countries.

Biosimilar education for Canadian nurses Biosimilars/Research | Posted 29/11/2019

In general, Canadian nurses are familiar with biosimilars. However, according to authors Sehdev et al., they may have knowledge gaps in their specific understanding, resulting in a significant unme...

Lupin to launch etanercept and pegfilgrastim biosimilars in the US Biosimilars/News | Posted 29/11/2019

India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a p...

The sluggish US biosimilars market Reports | Posted 29/11/2019

Juliana Reed, President of the Biosimilars Forum, gave a presentation on ‘The State of the Biosimilars Market’ at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on...