Generics

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.