Biosimilars
iBio and GE Healthcare form new global alliance
Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, and GE Healthcare, the health business of General Electric, announced on 26 July 2012 a new global alliance to commercialise plant-based technologies for the manufacture of biologicals and vaccines.
FDA urged to exclude plasma protein therapies from biosimilar pathway
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 mandate to create a new abbreviated process for the approval of biosimilars under the Biologics Price Competition and Innovation Act of 2009, which was part of the new healthcare reform law passed in March 2010 [1]. This potentially brings cheaper products to market sooner, and so increases the availability of affordable health care. However, it also means that manufacturers applying for approval for new biosimilars may be able to skip clinical testing if they can demonstrate sufficient similarity with reference products.
Deal struck over development of Herceptin biosimilar
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 clinical development and testing of biosimilar trastuzumab as an alternative to Roche’s blockbuster anticancer agent Herceptin. The deal follows the results of a phase I trial reported on 22 March 2012 showing bioequivalence between Synthon’s trastuzumab and Herceptin [1].
Positive results from phase I study with biosimilar insulin glargine
Leading biotech company Biocon announced on 25 July 2012 positive results from a phase I comparative study conducted in Germany of its biosimilar insulin glargine in type 1 diabetes mellitus (T1DM) patients.
Biosimilar monoclonal antibody approved in Korea
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.
US supreme court ruling means biosimilars pathway safe
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 is part of the act, is now also safe.
Biosimilar infliximab equivalence proven in phase III trial
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 – Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab) in terms of safety and efficacy in patients with active rheumatoid arthritis [1].
Copaxone sees off generics challenge
Teva received a major boost in June 2012, after a US court backed the Israeli firm in a patent dispute concerning its multiple sclerosis blockbuster Copaxone (glatiramer acetate).
US$67 billion worth of biosimilar patents expiring before 2020
Last updated: 20 January 2014
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 has been extended until 2028, scoring global sales of US$7.3 billion by December 2011; coming in second after Humira (adalimumab) with global sales of US$7.9 billion [1].
Phase I trial of biosimilar infliximab proves biosimilarity
Results from a phase I trial of biosimilar infliximab have proven the equivalence of South Korean biotechnology company Celltrion’s biosimilar (CT-P13) and the reference product – Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab) in terms of pharmacokinetic parameters, as well as in safety and efficacy in patients with active ankylosing spondylitis [1].
