Generics

Teva CEO about opportunities in generics and biosimilars

Generics/Research | Posted 15/03/2010

To retain its position in the long run, Teva Pharmaceutical Industries Ltd. aims at significant growth in the generic market in the years to come, says Teva CEO Mr Shlomo Yanai in an interview by Mr Haim Watzman published in Nature Medicine in March 2010.

Daiichi Sankyo unit to sell generic drugs in Japan

Generics/News | Posted 15/03/2010

Daiichi Sankyo Co. Ltd. said on 26 February 2010 it will set up a new subsidiary in April 2010 to produce and sell generic drugs in Japan, in – according to Mr Kazuhiro Shimamura in the Wall Street Journal Asia – a rare move by a domestic maker of branded prescription drugs to tap the growing market of low-priced pharmaceuticals.

EGA wants better Centralised Procedure and Decentralised Procedure for generics authorisation

Generics/General | Posted 03/03/2010

The European Generic medicines Association (EGA) presented ‘Vision 2015’, which aims to create a globally competitive generic industry, increase patient access to affordable quality medicines and ensure sustainable health care in Europe, e.g. by improving the EU's centralised procedure (CP) and decentralised procedure (DCP) for authorising medicines.

FDA: Counterfeit orlistat has risky sibutramine amount

Generics/News | Posted 22/02/2010

As reported by Scrip, the US FDA has re-iterated its concerns about a counterfeit version of GlaxoSmithKline's Alli (orlistat), which contains varying degrees of sibutramine rather than the correct active ingredient.

Biovail says Teva’s generic bupropion trial is too small

Generics/News | Posted 19/02/2010

As reported by Reuters, Biovail, Canada's biggest publicly traded pharmaceutical company said on 22 January 2010 that it believes a proposed clinical trial by Teva of a generic version of Biovail's sustained-release Wellbutrin XL (bupropion) antidepressant drug is too small and brief to be effective.

India urges WHO to ‘clearly promote’ generics

Generics/News | Posted 18/02/2010

As reported by Scrip on 25 January 2010, India has urged the World Health Organization (WHO) to ‘clearly promote’ generic drugs as a strategy for rational drug use.

Indian firms seek a higher profile in biosimilars

Generics/Research | Posted 12/02/2010

As reported by Anju Ghangurde in Scrip News of 13 January 2010, large Indian companies appear to be keen to develop their capacities and capabilities in the biosimilars segment, an area expected to take centre stage globally in the coming years. Some of this growing interest is being attributed to the projected decline in the global pipeline for generic small molecules by about 2013, as well as optimism that some large markets such as the US will soon put in place regulations to facilitate the entry of biosimilars.

Physicians still have concerns about the quality, reliability and interchangeability of certain generic medicines

Generics/Research | Posted 11/02/2010

In a study by Dr Mohamed Azmi Hassali et al. of the Universiti Sains Malaysia (USM), as published in the January 2010 Journal of Generic Medicines issue (published online 1 September 2009), physicians’ views on generic medicines are reviewed.

Opportunities and challenges to implementing the Quality by Design approach in generic drug development

Generics/Research | Posted 11/02/2010

In an article by Dr Ramaji Varu of Biocon, Bangalore, India, and Dr Amit Khanna of Novartis, Hyderabad, India, published in the January 2010 Journal of Generic Medicines issue (published online 17 November 2009) the opportunities and challenges to implementing the Quality by Design (QbD) approach in generic drug development are discussed.

Teva’s hedge with generic enoxaparin versus branded glatimir

Generics/News | Posted 05/02/2010

In the IN VIVO Blog of 14 January 2010, FDC-Windhover’s Biopharma Group Editor-in-Chief Michael McCaughan wrote that – apart from developing a long-term biosimilars strategy (as of 2015) – no one is in quite the same position in complex generics as Teva.