GaBI

Indian government encourages biosimilars

Fri, 03 Sep 2010 14:30:22 GMT

India has, by far, demonstrated the greatest acceptance of biosimilars. In recent years over 50 biopharmaceutical products have been approved for marketing in India, with more than half of them being biosimilars.

Good news for biosimilar enoxaparin sodium

Fri, 03 Sep 2010 14:24:29 GMT

French pharma giant sanofi-aventis (sanofi) has been denied a request to block sales of a generic version of its Lovenox blood thinner by a US district court.

US healthcare reform

Fri, 03 Sep 2010 14:19:03 GMT

The tide is finally changing in the US with reform of the healthcare system finally set to provide universal health care to most of the US population. This is great news for the American citizen, but what are the implications for generics and biosimilars in this changing environment?

Drug recalls and generic medicines

Fri, 03 Sep 2010 13:29:37 GMT

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.

The global generic medicines market

Fri, 03 Sep 2010 13:23:46 GMT

The global market for generic drugs was worth an estimated US$84 billion for 2009 and is expected to increase to a staggering US$168.7 billion by 2014.

International trends in generics: India

Fri, 03 Sep 2010 13:15:00 GMT

South Africa, home to 5.7 million HIV-positive people – more than any other country in the world – gives AIDS patients free drugs, most of which are generics that come from India. This is just one country, but representative of many that are keen to buy low-priced generic medicines from India. So much so that India now produces a quarter of the world’s generic medicines.

Can we have our cake and eat it?

Fri, 03 Sep 2010 13:12:04 GMT

Managing the cost of pharmaceutical expenditure is entirely the competence of individual EU Member States. As a result, Europe has developed into a patchwork of different systems of pharmaceutical pricing and reimbursement.

International trends in generics: the EU

Mon, 30 Aug 2010 13:42:46 GMT

Few studies have conducted an international price comparison of generic medicines as it is hard to access comparable data. A 2007 study by Prof. Dr. Steven Simoens examined national pricing policies in some EU countries and related them to generics prices (see Table 1).

How far does similarity go?

Wed, 25 Aug 2010 07:04:12 GMT

How much similarity does a biosimilar monoclonal antibody (mAb) have to show to its reference mAb? The European overarching biosimilar guideline states that a biosimilar needs to be ‘similar, in molecular and biological terms, to the active substance of the reference medicinal product.’ The guideline gives an example to highlight this, stating that an interferon alfa-2b would not be acceptable as a reference product to a biosimilar interferon alfa-2a1. Because interferon alfa-2a and alfa-2b differ in only one amino acid, the guideline thus indicates that the entire amino acid sequence of the two molecules should be identical.

What clinical trials will be required for biosimilar mAbs?

Wed, 25 Aug 2010 06:59:52 GMT

The relevant European guideline states that if the reference medicinal product has more than one indication, the efficacy and safety of a biosimilar has to be justified, if necessary by demonstrating it separately for each indication claimed. The guideline brings up the possibility of ‘extrapolating’ efficacy (granting several clinical indications that are licensed for the reference product, although only one of the indications has been studied in the clinical development programme of the biosimilar). This would not be done without serious consideration. The mechanism of action of monoclonal antibodies (mAbs) is usually complex and in many cases only partially understood.