Biosimilars/General
Extension of indications and manufacturing approval for biologicals in the US
Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received approval to manufacture a monoclonal antibody drug product.
FDA guidance sought on false and misleading information on biosimilars
Pharma giant Pfizer has asked the US Food and Drug Administration (FDA) to issue guidance ‘clarifying appropriate sponsor communications about the nature and properties of biosimilars’.
European nurses launch biosimilar switching guide
The European Specialist Nurses Organisations (ESNO) announced on 26 June 2018 the launch of a guide for switching from reference biologicals to biosimilars.
US pharmacies sue J&J for stifling infliximab biosimilars
Two major US pharmacy chains, Walgreen and Kroger, have sued healthcare giant Johnson & Johnson (J&J) in the US District Court Eastern District of Pennsylvania. The pharmacies allege that J&J prevented insurers from covering biosimilars of its blockbuster immunology drug Remicade (infliximab).
Biosimilars applications under review by EMA – June 2018
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.
Biosimilar infliximab blocked in Australia
Switzerland-based drug giant F. Hoffmann-La Roche (Roche) has gained a temporary order in an Australian Federal Court blocking Sandoz from launching its rituximab biosimilar.
AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar
Biosimilars maker Samsung Bioepis announced on 5 April 2018 that it had reached a ‘global resolution’ with pharma giant AbbVie ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).
Spanish associations sign biosimilars collaboration
The Spanish Association of Biosimilar Medicines (BioSim) announced on 21 March 2018 that BioSim and the Federation of Spanish Medical Scientific Associations (FACME) have signed a collaboration agreement that includes the creation of a joint working group to share up-to-date information on biosimilars.
WuXi Biologics expands its biologicals manufacturing facilities
China-based WuXi Biologics, headquartered in Wuxi city of Jiangsu Province, is expanding its biologicals manufacturing capacity with new facilities planned in Ireland, China, Singapore and the US.
Biosimilars highlights for 2017
There are many product launches and various topics such as naming, extrapolation, interchangeability and switching of biosimilars in 2017 [1]. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab‑qbtx), and Ogivri (trastuzumab-dkst), along with the approval of follow-on insulin lispro biological Admelog, by the US Food and Drug Administration (FDA).
