Biosimilars/General
Biosimilars applications under review by EMA – 2012 Q4
Last update: 23 August 2013
European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the 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’.
Call for clarity in FDA’s draft guidance on biosimilar meetings
Drug companies have made comments on FDA’s draft guidance for industry on formal meetings between the agency and biosimilars manufacturers. They believe that the guidance needs some revision to protect data and provide clarity.
Biologicals sales have almost doubled since 2006
Sales of biologicals have almost doubled from US$63.8 billion in 2006 to US$124.6 billion in 2012.
Biosimilars and US exclusivity
Currently, the legal pathway in the US for the approval of biosimilars is the Biologics Price Competition and Innovation Act (BPCI Act) of 2009.
Biosimilars applications under review by EMA – 2013 Q1
Last update: 12 April 2013
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the 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’.
Recall of anaemia drug highlights safety issues of NBCDs
US-based biotech firm Affymax announced on 24 February 2013 that it is recalling all lots of its red blood cell-stimulating medicine Omontys (peginesatide). This could have broader implications on how FDA evaluates follow-on non-biological complex drugs (NBCDs).
Pharma companies sue EMA to block release of data
US-based biotech companies AbbVie and InterMune have both sued EMA in a bid to block publication of clinical trial data for their drugs.
US FDA defends biosimilar substitution
US FDA Commissioner Margaret Hamburg defended the substitution of interchangeable biosimilars at the Generic Pharmaceutical Association (GPhA) Annual Meeting which was held in Orlando, Florida, USA, on 20–22 February 2013.
Biosimilars to replace 70% of chemical drugs
Biosimilars will replace some 70% of global chemical drugs over the next couple of decades, according to industry experts. This replacement will occur due to the better safety profiles of biosimilars compared to chemical drugs and the fact that many originator biologicals will lose their patent protection in the coming years, according to Mr Appaji, Director General of Pharmaceuticals Export Promotion Council of India (Pharmexcil).
Top developments in biosimilars during 2012
Much has happened in the biosimilars’ industry over the last year.
