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Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
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Soliris (eculizumab)
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Adalimumab biosimilars shaping market, research states
GlobalData has shared research on how the loss of exclusivity of AbbVie’s Humira (adalimumab) is shaping the biosimilars market.
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Approval expanded for generalised myasthenia gravis medicine
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.
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European Commission approves haematology biosimilar
A marketing authorisation for a biosimilar to eculizumab has been granted by the European Commission for paroxysmal nocturnal haemoglobinuria.
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Eculizumab biosimilar gets positive CHMP opinion
Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.
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EC approves Ultomiris for children and adolescents with PNH
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
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FDA approves treatment for rare neurological disorder
An injection to treat NMOSD has been given approval by the FDA and has received orphan drug designation.
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Top mid-cap biotech companies increased revenues to $26.5 billion in 2014, says GlobalData
7 April 2015 | By Victoria White
The combined total revenues for the peer group of 35 mid-cap biotech companies increased from $24.8 billion in 2013 to $26.5 billion in 2014, representing a Compound Annual Growth Rate (CAGR) of 21.9%, according to research and consulting firm GlobalData.
