Biosimilars
Mylan/Momenta announce development strategy for aflibercept biosimilar
US generics giant Mylan and partner Momenta Pharmaceuticals announced on 3 January 2017 their development strategy for their aflibercept biosimilar, M710.
Trastuzumab biosimilars receive EMA and ANVISA approval
Trastuzumab products from Celltrion Healthcare (Celltrion) and Biocon/Mylan have received approval in Europe and Brazil.
Switching to biosimilars in rheumatology
Researchers from Argentina, Brazil, Germany, the UK and the US investigated switching from originator biologicals to biosimilars [1].
EMA accepts application for pegfilgrastim biosimilar from USV
India-based biologicals specialist USV Biologics (USV) announced on 7 December 2017 that the application for approval for its proposed pegfilgrastim biosimilar has been accepted by the European Medicines Agency (EMA).
Biosimilars applications under review by EMA – January 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.
Additional clinical data for Cinfa’s pegfilgrastim biosimilar
Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 2 November 2017 additional clinical data for its candidate pegfilgrastim biosimilar (B12019).
FDA approves follow-on insulin lispro Admelog
Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on version of Eli Lilly’s Humalog (insulin lispro).
Switching failures with biosimilar etanercept
A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not work for all patients [1].
FDA approves biosimilar infliximab Ixifi
Pfizer announced on 13 December 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Regicide (infliximab).
Bevacizumab similar biologic launched in India
India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologic’ of bevacizumab, in India.
