Biosimilars/General
Originator biologicals and biosimilars under attack in UK and Japan
Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.
Comments on FDA’s public meeting on biosimilars
Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary suffixes and a request to waive bridging studies for biosimilars.
Biocon’s biosimilars plant gains clearance from FDA
India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicating that it is now compliant with US Food and Drug Administration (FDA) manufacturing requirements.
Samsung Bioepis sued over trastuzumab biosimilar but win for Celltrion’s biosimilar Inflectra
Roche’s Genentech has sued Samsung Bioepis regarding its trastuzumab biosimilar, but Celltrion has won its patent battle against Johnson & Johnson (J&J).
Improving understanding of biotherapeutics and biosimilars
Additional information on biosimilars and biotherapeutics have been published in Europe.
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.
