Biosimilars/General

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.