Biosimilars
Hospira looks to biosimilars and increased use of generics for growth
Injectable generics leader, Hospira, announced on 7 September 2011 at its investor day, that it will look to biosimilars and international expansion for future growth.
Five years of bioequivalence data from Cetero questioned
FDA is challenging five years of bioequivalence and other studies conducted at Cetero Research’s Houston facility in the US. This could affect both originator and generics companies alike, putting into question data provided to FDA to support new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
Biosimilars and the pharmaceutical industry
IMS Health predicts a slowing down of the growth in annual spending on medicines, with generics being one of the main contributing factors for this reduction.
Positive results for phase I trial of biosimilar erythropoietin
Hospira, self-proclaimed leader in injectable generics, announced on 6 September 2011 positive results from a phase I clinical trial of its biosimilar erythropoietin (EPO) carried out in the US in patients with anaemia associated with chronic renal (kidney) failure and chemotherapy.
Opportunities for biosimilars in emerging markets
By 2015, IMS Health expects spending on biosimilars to exceed US$2 billion annually, or about 1% of total global spending on biologicals [1]. This growth in biosimilars will be driven mainly by patent expiries coming in the next five years. However, due to the complexity and cost of developing biosimilars for western markets many biosimilar manufacturers are turning to emerging markets as being a much more cost-effective solution.
Biotech growth and biosimilar opportunities in India
The domestic biotechnology industry in India has seen rapid growth during 2010 and India is poised to attain a position of leadership in the biosimilars market according to reports from Ernst & Young India and Frost and Sullivan.
Doctors wary of using biosimilars for extrapolated indications
A report published on 24 August 2011 by research and advisory firm Decision Resources finds that the majority of US and European physicians are wary of using a biosimilar for an indication for which supporting clinical data are lacking.
Stada and Richter to collaborate on biosimilar development
German generics giant Stada Arzneimittel (Stada) and Hungary-based Gedeon Richter (Richter) announced on 30 August 2011 that the two companies have signed licence and collaboration agreements for the development and marketing of two biosimilars.
Controversial nomenclature for new biosimilars
How will FDA chose to name biosimilars? The answer it appears is not simple and could greatly affect the marketing costs associated with these products [1].
FDA and biosimilars: update on key themes
Since the existence of a legal pathway for biosimilars was made possible by the signing of the 2009 Biologics Price Competition and Innovation (BPCI) Act in 2010 by President Barack Obama, FDA has declared itself ‘open for business’ for biosimilars [1]. But what is the thinking of FDA and what should we expect from any guidance on biosimilars?
