News
Asian companies venture into biosimilars for kidney failure
2012-10-15 Malaysia-based Chemical Company of Malaysia Berhad (CCM) wholly-owned subsidiary CCM Duopharma Biotech Berhad and Korea-based biotechnology company PanGen Biotech announced on 19 June 2012 that… Read More »
Testing for unwanted immunogenicity from biologicals
2012-10-12 Immunogenicity caused by biologicals, both originator and biosimilar, is an important issue that was raised by Dr Wadhwa from the National Institute for Biological Standards… Read More »
Biosimilar monoclonal antibody approved in Korea
2012-10-10 South Korean biotechnology company Celltrion announced on 23 July 2012 that the Korean Food and Drug Administration (KFDA) had approved its first monoclonal antibody, Remsima.… Read More »
Australia moves towards pricing policy for biosimilars
2012-10-08 The Australian Pharmaceuticals Industry Council (PIC) has agreed to a broad strategy for the pricing of biosimilars so as to encourage the development and entry… Read More »
Deal struck over development of Herceptin biosimilar
2012-10-05 Netherlands-based biopharmaceutical company Synthon announced on 18 July 2012 that it has entered into a global licensing agreement with Amgen and Watson Pharmaceuticals for the… Read More »
FDA urged to exclude plasma protein therapies from biosimilar pathway
2012-10-03 FDA is being lobbied by patient and industry groups to exclude plasma protein therapies from its pathway for the approval of biosimilars. FDA has a… Read More »
Biosimilar infliximab equivalence proven in phase III trial
2012-10-01 Results from a phase III trial of biosimilar infliximab have proven the equivalence of South Korean biotechnology company Celltrion’s biosimilar (CT-P13) and the reference product… Read More »
US supreme court ruling means biosimilars pathway safe
2012-09-28 On 28 June 2012 the US Supreme Court ruled in favour of the bulk of the Affordable Care Act, meaning that the biosimilars pathway, which… Read More »
Mexican guidelines for biocomparables
2012-09-26 The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The agency is a decentralised… Read More »
US$67 billion worth of biosimilar patents expiring before 2020
2012-09-24 Twelve biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020, with Enbrel (etanercept) whose US patent… Read More »
