Biosimilars/News

EMA recommends approval of bevacizumab biosimilar Equidacent

Biosimilars/News | Posted 28/08/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting of marketing authorization for the bevacizumab biosimilar Equidacent, which is produced by Centus Biotherapeutics, a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics

EC approval for Sanofi’s insulin aspart biosimilar

Biosimilars/News | Posted 31/07/2020

The European Commission (EC) has issued marketing authorization for Sanofi’s insulin aspart biosimilar, which references Novo Nordisk’s product NovoLog and is used to treat type 1 and 2 diabetes.

EMA approves bevacizumab and teriparatide biosimilars

Biosimilars/News | Posted 24/07/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 June 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Aybintio and for the teriparatide biosimilars Livogiva and Qutavina.

FDA approves pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 24/07/2020

Pharma giant Pfizer announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Nyvepria (HSP-130).

FDA approves Mylan’s adalimumab biosimilar Hulio

Biosimilars/News | Posted 17/07/2020

The US Food and Drug Administration (FDA) has approved Mylan/Fujifilm’s adalimumab biosimilar Hulio (adalimumab-fkjp) on 7 July 2020. The product is the sixth adalimumab biosimilar to be approved by FDA and is manufactured by Japan-based Fujifilm Kyowa Kirin Biologics.

Celltrion launches Truxima in Brazil

Biosimilars/News | Posted 17/07/2020

On 27 May 2020, South Korean biotechnology company Celltrion Healthcare (Celltrion) announced that it had launched its rituximab similar biotherapeutic product Truxima (CT‑P10) in Brazil.

Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym

Biosimilars/News | Posted 10/07/2020

Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.

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.

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.