Biosimilars/General

FDA announces public hearing on biosimilars’ guidelines

Biosimilars/General | Posted 23/03/2012

FDA has announced a one-day public hearing to be held on 11 May 2012, in Silver Spring, Maryland, USA. During the meeting FDA hopes ‘to obtain input on recently issued draft guidelines relating to the development of biosimilar products.’

Also noted on biosimilars: 16 March 2012

Biosimilars/General | Posted 16/03/2012

Boehringer Ingelheim expands biologicals manufacturing capacity
Boehringer Ingelheim announced on 29 February 2012 the expansion of its biopharmaceutical development and manufacturing capabilities at its cell culture and microbial sites in Biberach, Germany and Vienna, Austria. The company has invested around Euros 17 million in order to improve good manufacturing practice and to expand cell banking, process science, cell line development and quality laboratories.

Source: Boehringer Ingelheim

WHO definitions of biosimilars

Biosimilars/General | Posted 09/03/2012

Confusion often surrounds terms used in the global field of generics and biosimilars [1].

Biosimilars interchangeability, increased costs and burden for FDA

Biosimilars/General | Posted 02/03/2012

Biosimilars manufacturers in the US are faced with many hurdles, including untested regulatory pathways, patent challenges and manufacturing issues associated with making such complicated molecules. On top of this drugmakers also need to take into account the higher marketing costs that may be associated with biosimilars.

Quality by design in biomanufacturing

Biosimilars/General | Posted 17/02/2012

In January 2011, FDA published its long-awaited guidance for industry on Process Validation: General Principles and Practices [1].This replaces the previous 1987 version (updated 2004) and it is understandably a big change for some whose whole career has been dominated by the previous approach. The question is: why was a change needed and how drastic is it?

Top developments in biosimilars during 2011

Biosimilars/General | Posted 13/01/2012

Over the past year, a lot has happened in the biosimilars industry.

FDA biosimilar user fees meeting

Biosimilars/General | Posted 16/12/2011

FDA announced a public meeting to be held on 16 December 2011 to discuss its recommendations for the agency’s biosimilars user fee programme for 2013–17.

Health Canada definitions of generics and biosimilars

Biosimilars/General | Posted 16/12/2011

Attention has been brought to the fact that there is confusion surrounding terms used in the global field of generics and biosimilars. Some of this confusion has been attributed to authorities in various regions of the world defining terms differently and other instances are due to a misunderstanding of the actual nature, characteristics, and method of research and manufacture of these biological products.

Speed to market critical in biosimilar development

Biosimilars/General | Posted 18/11/2011

For companies looking to develop biosimilars speed to market is critical, but this must not be done by sacrificing product quality, according to a report from Contract Research Organisation (CRO) Quintiles. The most successful biosimilar companies will be those who collapse their clinical, commercial, and regulatory thinking into a streamlined cohesive function in order to expedite commercialisation and optimise market access.

FDA definitions of generics and biosimilars

Biosimilars/General | Posted 18/11/2011

Confusion surrounding terms used in the global field of generics and biosimilars is a recognised problem.

The source of some of this confusion is due to authorities in various regions of the world defining terms differently and other instances are due to a misunderstanding of the actual nature, characteristics, and method of research and manufacture of these biological products.

Biobetter of trastuzumab on the horizon

Biosimilars/General | Posted 14/10/2011

TrasGEX, which is currently under development by German biopharma company Glycotope, is shaping up to be an improved version (or biobetter) of Roche’s blockbuster cancer drug Herceptin (trastuzumab). Trastuzumab targets the HER2 receptor, commonly overexpressed in a variety of cancers, such as HER2-positive breast and stomach cancer.

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).

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.

FDA and biosimilars: update on key themes

Biosimilars/General | Posted 26/08/2011

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?

FDA and biosimilars: process update

Biosimilars/General | Posted 19/08/2011

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?

Current status of biosimilar development

Biosimilars/General | Posted 01/07/2011

Widespread therapeutic use of biological pharmaceutical products appears to be inevitable. Nevertheless, the law governing approval of biosimilar products in the US is still not in place. The size of the biologicals market and impending patent expiries, however, are making approval of a practical pathway for biosimilars more urgent.

Market opportunities for biosimilars

Biosimilars/General | Posted 17/06/2011

Although growth in annual spending on medicines is set to reduce, there is still a huge market out there and spending on biosimilars is expected to increase in the coming years.

Enoxaparin biosimilar or not

Biosimilars/General | Posted 06/06/2011

A biosimilar of the low molecular weight heparin, enoxaparin, produced by Sandoz (Novartis’s generics division) was approved by the FDA on 23 July 2010. However, some question whether this was really a biosimilar or not.

Biobetters rather than biosimilars

Biosimilars/General | Posted 06/05/2011

‘Biobetters’, rather than biosimilars, are the next big opportunity for biopharm and contract research organisations (CROs) hoping to profit from patent expirations on biologicals, say experts.

The history of the US biosimilar regulatory pathway

Biosimilars/General | Posted 22/04/2011

The US, although it now has a legal pathway (with the approval of the Biologics Price Competition and Innovation Act [BPCI Act], which was signed into law on 23 March 2010 by President Barack Obama), does not yet have a practical pathway with guidance defined by the FDA.

Generics and biosimilars Initiative

News

Research

General