Generics

Bayer sues Teva over generic Yaz contraceptive

Generics/News | Posted 02/07/2010

On 15 June 2010, German-based Bayer Schering Pharma (Bayer) announced that it was suing the Israeli generic giant, Teva Pharmaceuticals (Teva), for false advertising and patent infringement in connection with Teva’s generic oral contraceptive, Gianvi. Teva’s product is sold as a generic version of Bayer’s leading oral contraceptive Yaz.

FDA creates new division to speed up generic approval times

Generics/General | Posted 25/06/2010

As the FDA’s Office of Generic Drugs (OGD) struggles to keep up with its growing backlog of abbreviated new drug approvals (ANDAs), the office is creating a new chemistry division that it hopes will allow speedier generic drug approvals.

Ranbaxy launches generic antiplatelet agent Prasita in India

Generics/News | Posted 25/06/2010

On 10 June 2010, Indian-based Ranbaxy Laboratories Limited (Ranbaxy) announced the launch of a generic version of Prasugrel in India. The product, called Prasita, is an antiplatelet agent for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Sanofi-aventis blocks generic Allegra

Generics/News | Posted 25/06/2010

On 14 June 2010, a US court backed sanofi-aventis and Albany Molecular Research in their bid to prevent Dr Reddy’s selling a generic version of the anti-allergenic medication, Allegra-D 24 Hour (fexofenadine HCl/pseudoephedrine HCl).

Teva forces Dutch market to use pre-filled MTX syringes

Generics/News | Posted 25/06/2010

Until recently, the generic disease-modifying anti-rheumatic drug methotrexate (MTX) was available in The Netherlands in large vials, of which (hospital) pharmacists prepared ready-to-use (RTU) syringes for the weekly treatment of patients with rheumatoid arthritis (RA).

Are generic medicines in Europe too expensive?

Generics/Research | Posted 18/06/2010

by Professor Steven Simoens, Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven, Leuven, Belgium

Is the quality of generic medicines under pressure?

Generics/News | Posted 11/06/2010

“You get what you pay for” runs the old adage, and concerns are being expressed that a number of firms providing clopidogrel in Europe have all sourced the active ingredient from the same Indian firm, Glochem Industries Ltd, which has failed a quality inspection.

Financial incentives to prescribe cheaper medicinal products

Generics/News | Posted 28/05/2010

On 22 April 2010, the Court of Justice of the EU (ECJ) ruled that public authorities may offer financial incentives encouraging doctors to prescribe cheaper medicinal products. Adding that “those authorities are required, first, to ensure that the incentive scheme is based on non-discriminatory objective criteria and, second, to make public the therapeutic evaluations relating to the scheme”. This is good news for the generics sector, as this can only lead to increased sales of cheaper generic medicines.

EMA wants recall of Acino’s generic clopidogrel with active substance of Indian Glochem

Generics/News | Posted 02/04/2010

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended the recall of all batches of eight centrally-authorised generic clopidogrel-containing medicines, for which the active substance was manufactured by Glochem Industries Ltd in its factory in Visakhapatnam, India. The medicines concerned are Clopidogrel A1 Pharma, Clopidogrel Acino, Clopidogrel Acino Pharma, Clopidogrel Acino Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel Ratiopharm GmbH and Clopidogrel Sandoz. The Marketing Authorisation Holder of all these medicines is Acino Pharma GmbH.

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.

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.

AstraZeneca, Teva settle Nexium, Prilosec patent disputes

Generics/News | Posted 05/02/2010

AstraZeneca has deferred the threat to its blockbuster drug Nexium (esomeprazole magnesium) in a settlement with Israel's Teva that is likely to delay generic competition for a further four years.

EU regulators request details of drug patent settlements

Generics/News | Posted 02/02/2010

The European Commission reported on 12 January 2010 that it requested information from several drugmakers in relation to patent settlement agreements made between July 2008 and December 2009.

European patients trust generic medicines

Generics/Research | Posted 02/02/2010

In total 2,800 patients participated in the European Health study by InSites Consulting. Seven out of ten participants indicated the ability to differentiate generic medicines from brand medicines. While generic medicines contain the same active ingredients as patented brands, we still discovered that 44% of patients who claim to be familiar with generic medicines do not believe this. However this does not detract from the effectiveness patients ascribe to ‘white products’. Eighty three per cent believe that generic medicines are equally effective as the original formula.

Sanofi-aventis still owns clopidogrel users patent for acute coronary syndrome, in contrast to most generic clopidogrels

Generics/News | Posted 01/02/2010

Since the European product patent on sanofi-aventis’ clopidogrel antiplatelet agent Plavixâ – one of the world's best-selling drugs with global sales of US$8.6 billion in 2008, co-marketed with Bristol-Myers Squibb – has expired, several generic clopidogrel products enter the European market. However, sanofi-aventis still owns the usage patent on one of the clopidogrel indications, namely on acute coronary syndrome.

Will Teva join Big Pharma by 2015?

Generics/News | Posted 25/01/2010

Teva Pharmaceutical Industries’ annual revenue will probably more than double to US$31 billion by 2015, as rising healthcare costs push patients and policy makers toward (bio)generic drugs, Chief Executive Officer, Shlomo Yanai, told analysts on 7 January 2010 in an Internet presentation from New York. According to FiercePharma, that would make it big enough to become one of the Top 10 drugmakers worldwide on the 2008 revenue ranking at least.

Steady gains in perceptions of generics in Japan

Generics/News | Posted 25/01/2010

As reported by Scrip News on 17 December 2009, the latest survey of patient and pharmacist perceptions of generic drugs in Japan shows a high percentage of patients would be willing to receive such products, while pharmacists view them as important in keeping down healthcare costs.

Should Indian generic firms partner with Big Pharma?

Generics/General | Posted 20/01/2010

After years of warding off generics, large pharmaceutical companies are embracing generic drug manufacturers and vying for a share of the off-patent drugs business. Indian generic companies, once considered business pariahs, are the focus of plenty of action, Anju Ghangurde reports in Scrip News of 9 December 2009.

Big Pharma’s generics entry and generic drug prices

Generics/General | Posted 20/01/2010

Big Pharma’s strategic detour into generics

Generics/General | Posted 20/01/2010