Biosimilars/General
FDA updates Purple Book for biologicals and biosimilars
On 21 February 2017, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the ‘Purple Book’.
Biosimilars of eculizumab
Last update: 20 October 2017
Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with paroxysmal nocturnal haemoglobinuria (PNH), for whom it improves quality of life but does not appear to affect the risk of death. It is also indicated for the treatment of patients with atypical haemolytic uremic syndrome (aHUS) – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy.
Biosimilars of abatacept
Last update: 28 April 2017
Abatacept is a modified antibody biological drug used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the function of particular cells (T-cells) in the immune system. This action modifies the inflammation and immune activity which cause the symptoms of rheumatoid arthritis.
FDA Commissioner discusses challenges and opportunities for biosimilars
The US Food and Drug Administration (FDA) approved its first biosimilar for cancer drug Avastin (bevacizumab) in September 2017 [1]. In light of this momentous event, FDA Commissioner Dr Scott Gottlieb spoke to medical reporter Laurie MicGinely, at The Washington Post’s Chasing Cancer Summit, about the challenges faced by biosimilars and the future opportunities in the US.
Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars
India-based biologicals specialist Biocon announced on 16 August 2017 that it was withdrawing its European Union (EU) marketing applications for its trastuzumab and pegfilgrastim biosimilars.
Biosimilars applications under review by EMA – August 2017
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.
WHO launches consultation on prequalification of biosimilars
The World Health Organization (WHO) announced in September 2017 that it would be launching its pilot project for prequalifying biosimilars in October 2017. The step is intended to make ‘some of the most expensive treatments for cancer more widely available in low- and middle-income countries’.
Australia’s TGA consults on naming of biologicals
Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced on 28 July 2017 that it was opening a consultation on how to name biologicals.
Setback in Biocon/Mylan’s biosimilar programme after GMP inspection
Biocon/Mylan’s biosimilar programme has hit a stumbling block after failing an inspection by the French inspecting authority (L’Agence nationale de sécurité du médicament et des produits de santé: ANSM).
UK investigation suggests Merck broke competition law
A provisional statement from the UK Competitions and Markets Authority (CMA) says that Merck Sharp & Dohme (MSD) ran an anticompetitive discount scheme for anti-inflammatory drug Remicade (infliximab).
