Biosimilars/News
Further lobbying over biosimilars
Brand-name drug companies are trying to weaken a provision of the US Patient Protection and Affordable Care Act that was designed to open up generic competition in biotechnology medicines and save billions of dollars. The industry, patients and providers are watching closely to see how the FDA will interpret the law, in documents that are expected to be released during late 2011.
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.
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.
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.
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.
Pfizer and India-based Biocon make biosimilar insulin deal
Biocon, India’s largest biotechnology company by revenue and Pfizer—the world’s biggest pharma company—announced on 18 October 2010 that they have entered into a strategic global agreement for the worldwide commercialisation of Biocon's biosimilar versions of insulin and insulin analogs (recombinant human insulin, glargine, aspart and lispro).
FDA holds public hearing on biosimilars pathway
The FDA has taken further steps towards implementing guidelines on the approval pathway for biosimilars in the US by holding a public meeting on the matter.
