Generics

Big Pharma finally warms to generic pariahs

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.

Very few API plants in China allowed to supply the EU

Generics/General | Posted 15/01/2010

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

Generics/General | Posted 15/01/2010

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

Generics/General | Posted 12/01/2010

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

Generics/News | Posted 12/01/2010

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

Generics/News | Posted 08/12/2009

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

Generics/General | Posted 08/12/2009

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

Generics/General | Posted 07/12/2009

India has alleged that some multinational companies have again been trying to bring its generics industry into disrepute.

Generic polypill could reduce heart disease

Generics/General | Posted 02/12/2009

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

Generics/News | Posted 02/12/2009

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

Generics/News | Posted 01/12/2009

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

Generics/General | Posted 01/12/2009

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%

Generics/News | Posted 23/11/2009

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

Generics/General | Posted 17/11/2009

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

Generics/General | Posted 12/11/2009

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

Generics/General | Posted 10/11/2009

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

Generics/Research | Posted 05/11/2009

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

Generics/Research | Posted 05/11/2009

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

Generics/News | Posted 29/10/2009

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

Generics/News | Posted 19/10/2009

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

Generics/News | Posted 16/10/2009

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

Generics/General | Posted 09/10/2009

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

Generics/Research | Posted 06/10/2009

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

Generics/News | Posted 30/09/2009

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

Generics/Research | Posted 14/09/2009

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

Generics/News | Posted 14/09/2009

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

Generics/News | Posted 11/09/2009

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

Generics/News | Posted 11/09/2009

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

Generics/News | Posted 04/09/2009

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

Generics/News | Posted 31/08/2009

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

Generics/News | Posted 31/08/2009

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

Generics/News | Posted 31/08/2009

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

Generics/Research | Posted 29/07/2009

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

Generics/Research | Posted 29/07/2009

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

Generics/General | Posted 29/07/2009

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

Generics/Research | Posted 29/07/2009

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.