News

Indian generics maker Cadila Pharmaceuticals Ltd (Cadila) has launched two new similar biologics in the country: Bevaro (bevacizumab) and Ritucad (rituximab).

The European Commission (EC) has granted marketing authorization for the trastuzumab biosimilar Zercepac (HLX02) on 27 July 2020. The product is produced by the Shanghai Henlius Biopharmaceutical Co Ltd (Henlius), making it the first China-made biosimilar to receive approval in Europe.

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

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.

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.

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).

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.

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

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).