Biosimilars
Ongoing monitoring of biosimilar G-CSF (filgrastim)
Sandoz is carrying out ongoing studies to ensure the safety of its biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim G-CSF). The MONITOR-GCSF study will recruit at least 1,000 patients from a minimum of 75 centres and follow them for a maximum of six cycles of chemotherapy.
Are biosimilars an easy option for big money
With the recent JP Morgan 29th Annual Healthcare Conference 2011 in San Francisco, US came a chance for reporters to quiz all the big name firms in one easy sweep. The result reported by Reuters is that the pharma industry is poised to dive into biosimilars.
Samsung to enter biosimilars market
Everybody is jumping on the biosimilars bandwagon these days, and it seems it is not just limited to pharmaceutical companies. Contract research organisation, Quintiles, announced on 28 February 2011 that it has entered into a deal with electronics giant Samsung to provide biologicals manufacturing and biosimilar development.
Biosimilar substitution in the EU
Although many things—including regulations for licensing of biosimilars—are harmonised within the EU, the attitude towards biosimilars and their substitution within the different countries of the EU varies widely.
Spectrum to develop biosimilar monoclonal antibody
California-based Spectrum Laboratories announced on 5 January 2011 that it has signed an agreement with contract research organisation Viropro for the development of a biosimilar version of Roche’s blood-cancer drug Rituxan (rituximab).
Biosimilars boost for South Korea
The South Korean Government has pledged to promote the biosimilars industry and plans to invest in the biosimilars industry in order to make Korea a market leader. The government will provide both financial and institutional support and is aiming to take a 22% share of the global market by 2020.
Gedeon Richter sign biosimilars’ agreement with Mochida
On 14 December 2010 Budapest-based Gedeon Richter and Tokyo-based Mochida Pharmaceutical (Mochida) announced that the two companies have entered into a comprehensive and long term license and collaboration agreement with respect to development and marketing of Richter’s biosimilar product portfolio.
Merck and Parexel form strategic alliance for biosimilars
Merck Sharp and Dohme (MSD – known in the US and Canada as Merck) and Parexel, a leading global biopharmaceutical services provider, announced on 12 January 2011 that they have entered into an alliance by which Parexel will provide a broad range of clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures is a division of MSD that focuses on biosimilars.
Sandoz announces biosimilar rituximab
Sandoz, the generic drug division of Swiss drug giant Novartis AG, announced on 10 January 2011 a phase II clinical trial for a biosimilar version of leading monoclonal antibody rituximab.
Contract manufacturing: top firms are investing
Lonza Group Ltd and ScinoPharm Taiwan Ltd, two leading manufacturers of active pharmaceutical ingredients (APIs), have struck separate deals to expand their capabilities to make biological drugs.
