The Employment Market
The global generics market is witnessing no slow-down, with the total number of patent expiries this year expected to top $50 billion. Leading the pack is Pfizer’s Lipitor (atorvastatin), patents for which will disappear in Europe during the course of the year and culminating with its US expiry in November. Plavix, Lexapro and Zyprexa will all be in the firing line within five years.
Whilst EU Member States are clearly looking to put the brakes on spending in general – evidence of its effect on generics can be seen in Germany where the tendering process caused prices to tumble – expansion is being fuelled by emerging markets, including China, India, Russia, Brazil and Turkey. Regulatory expertise in these growth regions is therefore becoming increasingly desirable.
Companies are now looking to balance off proficiency in established markets with knowledge of those that are emerging, as they seek to widen their offering and plan for future growth. The driving force is the desire to secure and maximise revenue. This is unsurprising, according to a report recently published by Ernst & Young, which maintains that China and India as well as two other emerging nations will be amongst the top 10 pharmaceutical market by 2010.
Generics manufacturers are taking advantage of the new reality, buoyed on by the fact that they are able to offer these markets affordable products. Originator companies are also, however, keen to join the party, and many of them already have generics wings. They are also looking to promote branded generics in many emerging countries in which citizens place great trust in established names. It is likely that only originators and larger generics manufacturers will flourish in this area, as the promotion of branded generics requires serious marketing muscle.
On the home front, the EU’s centralised procedure for marketing authorisations is growing in importance. Whilst it is compulsory for biotech products, orphan medicinal products and products that contain a new active ingredient not authorised in the Community before 2004 and used to treat AIDS, cancer, neurodegenerative disorder or diabetes, it is optional for any other products with new active substances. Generics manufacturers are also increasingly seeking to use the centralised procedure, although access problems remain. What is clear is that knowledge of the centralised approach to authorisation, both in terms of what exists in the EU (EMA) and US (FDA), is becoming more valued further afield, particularly in areas such as Asia/Pacific.
There is serious competition on the way, though. Biosimilars, unlike generics, are not exact copies of the reference product, and the regulatory pathway in the EU – not to mention the US – has been fraught with complexities. Their emergence has not been accompanied by the big bang that some experts predicted, as physicians lack confidence in them. However, with a good regulatory framework in Europe already in place, and guidelines for biosimilar monoclonal antibodies on the way, this area is set for good growth.
All Regulatory Opportunities