Generics/General

What is ‘tentative approval’ and how does it affect generics?

Generics/General | Posted 10/09/2010

Tentative approval by the FDA enables generics access to poor nations under a US initiative, which allows sale of generics to treat conditions where there is a significant public health impact, even though the originator drugs are still under patent protection.

Drug recalls and generic medicines

Generics/General | Posted 03/09/2010

In 2009 there were a record number of drug recalls according to Health Reform Watch. There were an amazing 1,742 drug recalls in 2009 compared to 426 in 2008.

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.

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.

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.

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.

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.

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

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

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 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.

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.

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.

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.

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.