Biosimilars
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?
China’s 5-year biotech investment fires clear warning to US
The Chinese Government has targeted biotechnology as a ‘strategic pillar’ industry, and has pledged to spend 2 trillion yuan (Euros 213. 3 billion; US$308.5 billion) on science and technology in the next five years alone [1]. This has sent out a clear warning to the US Government that China aims to become the world’s pioneer in biotechnology in the short to medium term. In response, despite being under increasing pressure to reduce overall health expenditure, the US Government has resisted calls to cut funding and pledged US$ 32 billion to its National Institutes of Health biomedical research programme for 2012 [2].
Is FDA requesting too much data to allow biosimilars to succeed in the US
The FDA’s recently published plans for a biosimilar approval pathway are facing increasing scrutiny. In an interview with Scientific American, Novel Health Strategies’ biosimilar market entry advisor, Dr Saurabh Aggarwal, said that the level of data required by FDA is too much for biosimilars to be able to succeed [1].
FDA and biosimilars: process update
Despite the fact that a legal pathway for the approval of biosimilars in the US has existed for more than a year, formal guidance has still not been issued by FDA. This has led many to question when, or even if, biosimilars will come onto the market in the US [1]. So what has FDA been doing in the meantime and how close are we to seeing some biosimilar guidance in the US?
FDA gives some insight into biosimilar pathway
FDA has outlined some of the requirements it intends to include in its biosimilars approval process in an article published in the New England Journal of Medicine [1]. The article is intended to give drugmakers, investors and other interested parties more insight into the approval process for biosimilars.
EMA proposes more precise definition for biosimilars
Members of the Biosimilar Medicinal Products Working Party at the EMA expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the term biosimilar in the literature [1].
