Generics

Big shifts in generics shares due to Dutch preference policy

Generics/News | Posted 30/03/2010

The percentage of generic prescribing in The Netherlands increased in 2009 from 56.3– 57.1% according to the Dutch Stichting Farmaceutische Kengetallen (SFK), as published in Pharmaceutisch Weekblad of 12 March 2010.

Pay-for-delay ban dropped from US healthcare reform bill

Generics/News | Posted 29/03/2010

The pay-for-delay ban amendment has been dropped from part of the US healthcare reform bill because of concerns it would not pass muster with congressional rules, according to a spokeswoman for US Senator Ms Herb Kohl, a Wisconsin Democrat who chairs the Special Committee on Aging, which held a hearing on drug prices on 18 March 2010, as reported by Pharmalot.

Teva with ratiopharm market leader in European generics

Generics/News | Posted 26/03/2010

On 18 March 2010 Teva announced that it has entered into a definitive agreement to acquire ratiopharm, Germany's second largest generics producer and the sixth largest generic drug company worldwide, for an enterprise value of Euros 3.625 billion. The transaction is subject to certain conditions including relevant regulatory approvals. On a pro forma basis, the combined company would have had 2009 revenues of US$16.2 billion. Teva expects to complete the transaction by year-end 2010.

Generic substitution of cyclosporin sometimes undesired

Generics/General | Posted 26/03/2010

The bio-equivalence criteria of the Dutch Medicines Evaluation Board (CBG-MEB) offer insufficient guarantee for a safe substitution of generic medicines in transplantation medicine, argue Internist-Nephrologist/Clinical Pharmacologist Teun van Gelder of the Erasmus MC and Professor of Surgery Robert Porte of the University of Groningen –both members of the board of the Nederlandse Transplantatie Vereniging (NTV) – in Pharmaceutisch Weekblad of 29 January 2010.

FDA adds Boxed Warning to clopidogrel label: drug less effective in poor metabolizers with CYP2C19 gene variant

Generics/News | Posted 23/03/2010

Sanofi-aventis and Bristol-Myers Squibb announced on 12 March 2010 revisions to the US prescribing information for its anti-blood clotting drug Plavix (clopidogrel bisulfate).

AstraZeneca signs branded-generics deal with Torrent to boost emerging-markets presence

Generics/News | Posted 18/03/2010

AstraZeneca announced on 11 March 2010 a license and supply agreement with Torrent Pharmaceuticals. Torrent will supply to AstraZeneca a portfolio of generic medicines for which Torrent already has licenses in a range of countries. Working in partnership with Torrent, AstraZeneca intends to brand and market these products in many of its emerging markets, where it already has a strong commercial footprint.

India claims to be world leader in generics exports

Generics/General | Posted 17/03/2010

The Indian government has said that India ranks top in the world in exporting generic medicines, with a worth of 50,000 billion rupees a year. The country is now exporting to more than 200 nations worldwide, and exports totalled around US$8 billion in 2008-9, the majority going to the US and Europe, according to ‘Union Minister of State for Chemicals and Fertilisers Srikanta Jena’. ‘The industry’s achievements could create more than 500,000 high-value jobs in India and provide the nation with low-cost treatments for life-threatening conditions such as malaria and tuberculosis’, he added.

FDA warning letter to Chinese API supplier Xian Libang Pharmaceutical

Generics/News | Posted 17/03/2010

The FDA has warned Xian Libang Pharmaceutical Co. Ltd, a maker of active pharmaceutical ingredients (APIs); because its quality control unit failed to detect that an employee had manipulated testing data on incoming raw materials. The failure could affect drugmakers that use the company as a supplier. Xian Libang has been asked to provide a list of all lots of APIs shipped to the US that were released based on non-existent, inaccurate or unreliable test data, according to a warning letter of 28 January 2010 recently posted to the FDA’s website.

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.