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Janssen Biotech files lawsuits for infringement of cell culture media patent posted 26/08/2016

In ongoing litigation over infliximab biosimilars, Janssen Biotech, manufacturer of Remicade (infliximab), has filed two new...

Mylan and Biocon submit pegfilgrastim biosimilar to EMA posted 19/08/2016

Mylan and Biocon announced on 21 July 2016 that the regulatory submission for their proposed pegfilgrastim biosimilar (LA-EP2...

Bevacizumab similar biologics launched in India posted 19/08/2016

Generics makers Reliance Life Sciences (Reliance) and Hetero have both launched similar biologics of Roche’s blockbuster canc...

Samsung Bioepis adalimumab biosimilar submitted to EMA posted 12/08/2016

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 18...

FDA rejects Sandoz’s biosimilar pegfilgrastim application posted 08/08/2016

Novartis disclosed on 19 July 2016 that the application by its Sandoz unit to market a biosimilar version of pegfilgrastim ha...

 

Research

Pharmaceutical price regulation in Saudi Arabia: a countdown to affordable biosimilars posted 30/08/2016

The pricing of pharmaceuticals and biosimilars is generally subject to national regulatory control. Regulation is in place to...

Positive phase III results for Amgen’s trastuzumab biosimilar posted 26/08/2016

Results of a study of Amgen and Allergen’s trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab) have ‘ruled o...

Pharmacovigilance of biologicals in Denmark posted 21/08/2016

As a result of the increasing use of biologicals and biosimilars in Denmark, the Ministry of Health (MoH) in partnership with...

Evolution of biosimilars in developed and developing countries posted 21/08/2016

The development of biologicals has experienced continuous growth over the past three decades. The expiration of patent protec...

Biosimilars: the benefits need to be communicated posted 19/08/2016

Extrapolation may be the most contentious issue of biosimilar development, but it is also its single greatest benefit, says D...

 

General

Biosimilars of basiliximab posted 30/08/2016

Basiliximab is a chimeric mouse-human monoclonal antibody to the α chain (CD25) of the IL-2 receptor of T cells. It is an imm...

Biosimilars of infliximab posted 26/08/2016

Last update: 26 August 2016Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It...

Biosimilars of ranibizumab posted 26/08/2016

Last update: 26 August 2016Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as...

Biosimilars of omalizumab posted 26/08/2016

Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobu...

Biosimilars approved in the US posted 26/08/2016

Last update: 19 August 2016In the US, a legal framework for approving biosimilars was established in 2009, via the...

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