Generics
Hospira’s generic antibiotic Meropenem approved in US
On 22 June 2010, Hospira announced that it had received approval from the FDA for its generic antibiotic, Meropenem. This is the first generic launched in the antibiotic class and Hospira is the first to market.
Teva gains approval for generic breast cancer and anti-depressant drugs
The Israeli generics’ giant Teva Pharmaceuticals is racing ahead in the generics game with the announcement of the approval by the FDA of two new drugs for treatment of breast cancer and depression.
Bioequivalence testing for generics
Bioequivalence studies, consisting of single-dose pharmacokinetic evaluations, are required for the registration of most generic drug formulations. In general, bioequivalence testing provides a useful comparison for different products containing the same active ingredient. Bioequivalence studies therefore play a key role in the development of new generic products as well as in the post-marketing phase of innovator products.
Astra Zeneca losing generic esomeprazole battle
On 17 June 2010, AstraZeneca announced that its efforts in Canada to stop the launch of a generic version of its patented, stomach-acid-relief drug Nexium (esomeprazole), were rejected by the Canadian court.
Bayer sues Teva over generic Yaz contraceptive
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
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
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
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
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?
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?
“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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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?
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
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?
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
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 strategic detour into generics
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 finally warms to generic pariahs
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.
Very few API plants in China allowed to supply the EU
Member of the European Parliament (MEP) Amalia Sartori has questioned the European Commission (EC)’s estimate that 20,000 active pharmaceutical ingredient (API) producers supply the EU, which was used to justify not having mandatory inspections.
Confusion about number of European API plants in China
A member of the European Parliament (MEP) has questioned the European Commission (EC)’s estimate that 20,000 active pharmaceutical ingredient (API) producers supply the European Union (EU), which was used to justify not having mandatory inspections, and the CEO of Hovione added that the numbers have been “dramatically misunderstood”.
Death sentence for six Chinese drug fakers
The Times of India reported on 10 December 2009 that six Chinese traders who exported fake anti-malaria drugs to Nigeria under the “Made in India“ label have been sentenced to death, the Ministry of Commerce in Beijing has said. But the ministry gave no further details about the identity of the traders.
EGA warning sounded over generic drug tenders
European Generic medicines Association (EGA)’s newly elected President, Mr Didier Barret, called for a “sustainable pricing system” for generic medicines to address unfair competition caused by large-scale government tenders for the products. Mr Barret, who also serves as head of Mylan's operations in Europe, the Middle East and Africa, made the remark as the organisation works on recommendations for expediting the approval of copycat drugs after patent expiration.
EU to seek details of drugmakers' patent deals
EU regulators will ask drug companies for details of deals with makers of generic medicines as part of a crackdown on firms suspected of blocking cheaper treatments, a European Commission (EC) official said on 19 November 2009.
Pfizer aims for Japanese generics market
Yet another US drugmaker is making eyes at Japan. Pfizer, the world's largest drugmaker, said on 19 November 2009 that it may start selling generic drugs in Japan from 2011 as part of its efforts to diversify its operations.
Multinationals trying to bring Indian generics into disrepute
India has alleged that some multinational companies have again been trying to bring its generics industry into disrepute.
Generic polypill could reduce heart disease
Could a combination of three blood-pressure-lowering drugs at low doses, with a statin, aspirin, and folic acid in one pill (the polypill), reduce cardiovascular events by more than 80% in healthy individuals? This was examined in a study funded by Cadila Pharmaceuticals in Ahmedabad, India (that wants to market the polypill as the ‘Polycap’), in which the effect of such a pill was assessed on blood pressure, lipids, heart rate, and urinary thromboxane B2, as well as its tolerability.
Growing generic injectables market: a cousin to biosimilars
Drugmakers are waking up to the opportunities in the generic injectables market for several reasons, not least of which are the high-profit margins the products can deliver. The segment also involves fast-growing therapeutic areas like oncology, anti-infectives and central nervous system (CNS) disorders. And for companies with an eye on the long-term prize, commercial and manufacturing experience in specialty generics could pave the way for a smoother entry into the biosimilars market when a regulatory pathway for low-cost biologics is created in the US.
India and EU to resolve generic drug dispute
India will resolve a dispute with the EU over generic drugs in an amicable way, Trade Minister Anand Sharma said on 6 November 2009.
Competition in China’s generic drug market intensifies
Patent protection for 35 kinds of the best-selling drugs is on track to expire by 2010, including medicines for the treatment of ulcers, hypertension and hyperlipemia. This is expected to have a major impact on the Chinese pharmaceutical industry, where generic drugs account for 97% market share. Industry analysts pointed out that although China has a large production scale of generic drugs, the level of technology remains relatively low. China is home to more than 6,000 pharmaceutical makers. Most of them battle it out at the low end of the price scale with the result that, the country’s profit margin in generic drugs is only equal to one-sixth of the international average.
Generics drive Dr Reddy's Q2 revenues up 14%
On 23 October 2009, Dr Reddy's Laboratories in India reported a 14% increase in consolidated revenues to Rs18.4 billion (Euros 263.94 million) for the second quarter that ended on 30 September 2009, driven by growth in the generics business.
FDA compared generic and innovator drugs based on 12 years of bioequivalence data
In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the same rate and extent of absorption as (i.e., is bioequivalent to) the innovator drug product. Thus, most orally administered generic drug products in the US are approved based on results of one or more clinical bioequivalence studies.
Exposure-response analysis on bioequivalent carbamazepine tablets not clinically relevant proof for toxicity differences
Generic immediate-release carbamazepine tablets are AB-rated generic versions of Novartis’s Tegratol. In this market, Taro is the leading supplier with half the market. Teva Pharmaceutical Industries Ltd follows with more than a quarter of the market, and Sun’s Caraco is the third-leading supplier with a share of about 18%. The only other supplier currently in the market is Apotex.
Post-marketing pharmacokinetic bioequivalence between generic and branded amoxicillin formulations
Amoxicillin is a moderate-spectrum, bacteriolytic, β-lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. It is usually the drug of choice within the class because it is better absorbed, following oral administration, than other β-lactam antibiotics.
Switching statins in Norway after new reimbursement policy
Norwegian scientists assessed the changes in statins prescribing in Norway after implementation of the new reimbursement regulations for statins in June 2005, as published in the British Journal of Clinical Pharmacology of October 2007 by Ms Solveig Sakshaug of the Norwegian Institute of Public Health in Oslo.
Possible economic benefits from generic and therapeutic statin substitution
The group of Associate Professor O Klungel of Utrecht University, The Netherlands, assessed the potential annual savings due to generic and therapeutic substitution of statin therapy for the general Dutch population, taking the patients’ medical histories into account. Pearl Gumbs and colleagues published the study in the British Journal of Clinical Pharmacology in November 2007.
Actavis launches generic challenge to Pfizer’s Lipitor
On 1 October 2009, Actavis, the Iceland-based generic company, launched the most high-profile commercial challenge in Western Europe to Pfizer’s best-selling and patent-protected medicine.
Many potential buyers as sale of Ratiopharm begins
The process of divesting Ratiopharm, the world's fourth-largest generic drugmaker, owned by the conglomerate formerly run by German billionaire Mr Adolf Merckle who committed suicide at the start of the 2009 is underway.
FDA approves generic prescription-only version of Plan B emergency contraceptive levonorgestrel for women ages 17 and under
The US FDA on 24 June 2009 approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.
Safety and compliance fears delay UK’s generics substitution
Plans to allow pharmacists to save the UK’s National Health Service (NHS) money by overruling doctors' prescriptions for branded medicines have been delayed after concerns about patient safety and compliance.
Big pharmaceutical firms start to embrace generics
President Barack Obama recently posed an existential question to those around him. “If there’s a blue pill and a red pill, and the blue pill is half the price of the red pill and works just as well, why not pay half the price for the thing that’s going to make you well?” Thus he captured one of two powerful global trends forcing pharmaceutical giants to look for a new business model.
US and EU get tough on 'pay-for-delay’ deals
Forces are aligning against ‘pay-for-delay’ patent deals, reported FiercePharma. After years of expressing contempt for the US Federal Trade Commission's (FTC) fight against the deals, the US Department of Justice (DOJ) has now signed up to the cause. In an appellate court filing, the DOJ said that it is unlawful for branded drugmakers to pay generic firms to stand down from patent challenges – unless the drugmakers can justify the deal.
Brand-name drugs are not more effective than generic versions for treating cardiovascular disease
A recent review in Evidence-Based Medicine by Dr Braden Manns of the University of Calgary in Canada studies the question whether generic drugs are as effective as brand-name drugs for treating cardiovascular disease.
Generic drug companies adapt to survive
The prospects seem bright for generics companies. Healthcare systems are increasingly looking for ways to cut costs, and patents are expiring on a growing number of medicines produced by innovative pharmaceutical companies. Yet recent forces have intensified not only the traditional tensions between the generic producers and their innovative rivals, but also among the generic companies themselves. Therefore the mood of many of the delegates at the European Generic medicines Association annual meeting recently held in Barcelona, Spain, was gloomy, as reported by Mr Andrew Jack in the Financial Times.
Conflicting interpretations of data exclusivity and non-authorised medicinal products
The European Court of Justice (ECJ) has handed Shire Plc and Janssen-Cilag Ltd, a Johnson & Johnson (J&J) company, a victory against Generics [UK] Ltd in a case involving the Alzheimer's treatment Reminyl. The court's ruling is in line with the rejection of Generics UK’s marketing authorisation for a form of galantamine by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA decision was based in part on an attempt by the generic-drug maker to reference a drug approved in Austria in 1963. The marketing authorisation for Nivalin (galantamine), the drug Generics UK referenced, was not updated after Austria joined the EU to comply with European Community law and cannot be used as a reference product. Nivalin was sold by Waldheim Pharmazeutika, which had approval to market the drug as a treatment for polio until 2001. Janssen-Cilag entered into an agreement with Waldheim to gain marketing authorisation for galantamine in 2000, to be sold under the brand Reminyl for Alzheimer's disease.
EvaluatePharma: Generic players impress in the first half
Which pharma firm is the most profitable? A new analysis of net margins by EvaluatePharma tagged companies for profitability, and the winner was not one of the big pharma companies, e.g. Johnson & Johnson or Pfizer, but PDL BioPharma:
FTC and Teva disagree on 'pay-for-delay' deals savings
In a speech on 23 June 2009 before the Center for American Progress in Washington, DC, USA, Federal Trade Commission (FTC) Chairman Jon Leibowitz said that an internal FTC analysis projects that stopping collusive ‘pay-for-delay’ settlements between brand and generic pharmaceutical firms would save consumers US$3.5 billion (Euros 2.5 billion) a year and also reap significant savings for the federal government, which pays approximately one-third of all prescription drug costs. Mr Leibowitz urged Congress to pass pending legislation to ban or restrict such anticompetitive patent settlements, in which manufacturers of brand-name drugs pay potential generic competitors to stay out of the market, as a way to control prescription drug costs, restore the benefits of generic competition, and help pay for healthcare reform.
Teva looking for ‘major’ acquisition
Just a year after swallowing the US$7.4 billion (Euros 5.3 billion) Barr Laboratories buy, Teva Pharmaceutical Industries is ready for another ‘major’ acquisition and may look beyond generic drugs for the purchase, CEO, Mr Shlomo Yanai, said. According to him, Teva is seeking targets to diversify in branded medicines as well as increase its market share in generic drugs. “If we find a target that is in line with our strategy in the specialty area, in the biotechnology area, we definitely are going to consider it,” Mr Yanai said. “We are not limiting ourselves to buying only generic companies.” He declined to name possible targets.
Watson to acquire Arrow to double generics business
Watson Pharmaceuticals announced it has entered into a definitive agreement to acquire privately held Arrow Group for US$1.75 billion (Euros 1.25 billion) in cash and stock. The combination of Watson and Arrow will result in a global pharmaceutical company with over US$3 billion (Euros 2.15 billion) in revenue, commercial operations in over 20 countries, and a robust product portfolio and pipeline. Watson expects the transaction to close in the second half of 2009, and be accretive to cash earnings per share in 2010 before synergies.
Pfizer plans partnerships and acquisitions in generics
Pfizer, the world's biggest drugmaker, is seeking deals with generic pharmaceutical manufacturers to increase sales of medicines that have lost patent protection.
International comparison of generic medicine prices
The introduction of generic price-regulated systems in many European countries, the trend towards international generic medicine companies, and competition from Indian companies emphasises the need to gain insight into international prices of generic medicines.
European generic prescribing trends and biosimilars
Pressure to control pharmaceutical expenditure and price competition among pharmaceutical companies is fuelling the development of generic medicines markets in ambulatory care in Europe.
Growing western generic APIs markets in India and China
The developing countries India and China represent growing markets for active pharmaceutical ingredients (APIs) from western regulated markets. This is the conclusion of Ms Kate Kuhrt, Director of Generics and API Intelligence at Thomson Reuters. “With the pharmaceutical markets in India and China expected to continue to grow at double-digit rates, while traditional pharmaceutical markets, such as the US, Japan and Western Europe remain stagnant, it is no surprise that many API manufacturers have set their eyes on India and China”, she states.
Branded cardiovascular drugs not better than generics
In December 2008, the Journal of the American Medical Association published an article on the clinical equivalence of generic and brand-name drugs used in cardiovascular disease by Aaron Kesselheim, et al. of Harvard Medical School, Boston, MA, USA.
Pressures on generic medicines put EU healthcare at risk
“The future of the European generic medicines industry is under serious threat, which places both the sustainability of European health care and the European industrial competitiveness at serious risk,” warned Mr Greg Perry, Director General of the European Generics medicines Association (EGA), at an EGA conference on healthcare sustainability on 31 March 2009 in Prague, Czech Republic.
Nomura: Generics growth will be steady for EU but anaemic for US
Between now and 2012, growth in the European generics market is expected to expand at less than 10% a year according to Ms Frances Cloud, co-head of healthcare investment banking at Nomura International, as she told the World Generics Medicines Congress Europe 2009, held in London, UK, in February.
