Biosimilars
Trastuzumab biosimilar Kanjinti is stable over extended storage periods
An investigation of the quality and in-use stability of diluted trastuzumab biosimilar Kanjinti (also known as ABP 980) versus the reference trastuzumab demonstrated no clinically meaningful differences in stability and activity over extended storage periods, according to Crampton et al. [1].
EMA approves bevacizumab and teriparatide biosimilars
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
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).
Biosimilar pipelines for Korean firms looking healthy
Korean companies are becoming more and important both in the country but also worldwide when it comes to developing biosimilars.
FDA approves Mylan’s adalimumab biosimilar Hulio
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.
Quotas improve biosimilar use in Germany
An assessment of the role of cost control measures on biological drugs in Germany finds that quotas for biosimilars are in some cases associated with increased use and are overall more effective than priority prescribing [1].
New Zealand IBD charity releases position statement on biosimilars
The charity Crohn’s and Colitis New Zealand has released a position statement on biosimilars, although there are not yet any biosimilars for inflammatory bowel disease (IBD) on the market in New Zealand.
Celltrion launches Truxima in Brazil
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.
Biosimilars applications under review by EMA – July 2020
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym
Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.
