Biosimilars/General
Merck launches biosimilars educational resource for patients
US pharma giant Merck (known as MSD outside the US and Canada) has launched an online resource intended to be used as an educational platform for patients, caregivers and the healthcare community.
Court rules in favour of Apotex in biosimilars dispute
Biosimilars specialist Apobiologix, which is part of the Apotex group, announced on 9 September 2016 that it had won its battle in the US against biologicals giant Amgen with respect to its filgrastim (Grastofil) and pegfilgrastim (Lapelga) biosimilars.
Biosimilar User Fee Act reauthorization
On 16 September 2016, the US Food and Drug Administration (FDA) released the Biosimilar User Fee Act II (BsUFA II) performance goals letter, attracting support from industry associations.
Biosimilars applications under review by EMA – August 2016
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.
Biosimilars of basiliximab
Basiliximab is a chimeric mouse-human monoclonal antibody to the α chain (CD25) of the IL-2 receptor of T cells. It is an immunosuppresant agent used to prevent immediate transplant rejection in people who are receiving kidney transplants, in combination with other agents.
WHO naming of biosimilars
The World Health Organization (WHO) has proposed a system of naming for biosimilars, which has been commended by some groups [1], but criticized by others.
Sandoz plans to launch five more biosimilars by 2020
Sandoz, the generics division of Novartis, has announced plans for five major global biosimilar launches by 2020.
Roche sues India’s drug regulator over Avastin ‘similar biologics’
Switzerland-based drug giant Roche has sued the Drug Controller General of India (DCGI) in the Delhi High Court over ‘similar biologic’ versions of its cancer blockbuster Avastin (bevacizumab).
Japan proving to be a favourable market for biosimilars
Uptake of biosimilars in Japan is on a par with generics use for some products, making Japan a lucrative market for biosimilars makers.
Benepali wins Danish tender for etanercept
Denmark’s drug procurement agency Amgros has chosen the etanercept biosimilar Benepali, made by Samsung Bioepis, as the priority drug for treating rheumatoid arthritis rather than the originator biological (Amgen’s Enbrel).
