Biosimilars

Denmark achieves 83% reduction in adalimumab costs through switching

Biosimilars/Research | Posted 10/07/2020

Spending on adalimumab in Denmark decreased by almost 83% between September and December 2018, thanks to a mandatory switching policy.

Revance and Mylan move forward with Botox biosimilar

Biosimilars/News | Posted 10/07/2020

US firm Revance Therapeutics (Revance) announced on 1 June 2020 that its partner, US-based drugmaker Mylan, had decided to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to Allergan’s cosmetic blockbuster Botox and Botox Cosmetic (onabotulinumtoxinA).

Japanese approval for first adalimumab biosimilar

Biosimilars/News | Posted 03/07/2020

Japan-based Fujifilm Kyowa Kirin Biologics announced on 29 June 2020 that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its adalimumab biosimilar FKB327 in Japan.

Biosimilars in Belgium: increasing competition

Biosimilars/Research | Posted 03/07/2020

Competition following the entry of biosimilars is still limited in Belgium, which is mirrored in low biosimilar market shares. Although (short-term) cost savings are realized by the implementation of mandatory price reductions on originator medicines (and obtaining high biosimilar market shares should thus not be a goal in itself), biosimilars can play a key role in ensuring the long-term sustainability of the Belgian off-patent biologicals market.

Positive phase I results for Innovent’s ipilimumab copy biological

Biosimilars/Research | Posted 03/07/2020

China-based Innovent Biologics (Innovent) announced on 3 June 2020 positive phase I results for its candidate ipilimumab copy biological, IBI310.

EC approval for etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/07/2020

The European Commission (EC) has granted marketing authorization for the etanercept biosimilar Nepexto (YLB113), developed by US-based drugmaker Mylan and its partner India-based generics maker Lupin.

China approves bevacizumab copy biological Byvasda

Biosimilars/News | Posted 26/06/2020

China-based drugmaker Innovent Biologics (Innovent) announced on 19 June 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved Byvasda (IBI-305), a bevacizumab copy biological.

Successfully transitioning patients with IBD to biosimilars

Biosimilars/Research | Posted 26/06/2020

Pharmacists and physicians from the Boston Medical Center describe the successful transition of patients with inflammatory bowel disease (IBD) using the originator infliximab biological, Remicade, to the infliximab biosimilar, Inflectra (infliximab-dyyb) [1].

Canada approves pegfilgrastim biosimilar Ziextenzo

Biosimilars/News | Posted 26/06/2020

Canada’s drug regulator, Health Canada, has approved the pegfilgrastim biosimilar Ziextenzo (LA-EP2006). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

EULAR recommendations for DMARDs in rheumatoid arthritis

Biosimilars/Research | Posted 26/06/2020

The European League Against Rheumatism (EULAR) has updated its recommendations on the management of rheumatoid arthritis (RA) using synthetic and biological disease-modifying antirheumatic drugs (DMARDs) [1].