Biosimilars

EMA comparability studies limiting biosimilar success

Biosimilars/Research | Posted 16/09/2011

The EMA’s comprehensive biosimilar regulatory pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, is a barrier for the development of clinically superior compounds, according to innovation researchers at Utrecht University, Utrecht, The Netherlands [1].

Biosimilars: barriers to entry and profitability in the EU and US

Biosimilars/Research | Posted 16/09/2011

The implications of the US biosimilars law and the pending patent expiries of the 12 major biological products in the EU and the US will have an impact on the profitability and viability of the biosimilars industry [1].

The market for global and European biosimilars

Biosimilars/Research | Posted 16/09/2011

Due to expiring patents for brand name products, cheaper generics are expected to grab market share [1]. This is not surprising due to the list of blockbuster drugs losing their patent protection in 2011 and 2012. These include the world’s best-selling drug, Lipitor (atorvastatin), which in 2010 had almost US$13 billion in worldwide sales, accounting for 15.8% of Pfizer’s total revenue [2].

Hospira looks to biosimilars and increased use of generics for growth

Biosimilars/News | Posted 16/09/2011

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

Biosimilars/General | Posted 16/09/2011

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

Biosimilars/Research | Posted 09/09/2011

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

Biosimilars/News | Posted 09/09/2011

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

Biosimilars/Research | Posted 09/09/2011

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

Biosimilars/General | Posted 02/09/2011

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

Biosimilars/Research | Posted 02/09/2011

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.