Abstract
The current business development activity of generic pharmaceutical companies is changing the face of the global generic industry with the acquisition of Allergan by Actavis and the Sun-Ranbaxy acquisition. The latter is highly focussed on the generic market and building a global generic and OTC footprint whilst the former is driven by a focus on speciality products and the USA marketplace.
In the biosimilar space, at the time of writing, the Russian companies and the Chinese companies are both seeking from their governments clear approved regulatory guidelines for biosimilars. When these are approved and published this will probably leave a global montage of regulatory guidelines of which many will be close to the European Medicines Agency guidelines.
The product portfolios of the innovator pharma companies are now being driven by the Breakthrough Therapy Designation (BTD) recently issued by the FDA. BTD means the medicine is indicated to treat serious diseases and the early clinical evidence available demonstrates there is a substantial improvement over existing therapies. The FDA introduced BTD for the first time in mid 2012. Of those medicines which have since applied for BTD status, only a quarter have actually been granted the designation. The practical benefit of BTD is that there is intensive guidance available from the FDA which is likely to increase the speed of regulatory approval to the USA market. It is interesting to note the modest number of monoclonal antibodies in the current list of BTD designated medicines. This trend will eventually be reflected in the generic patent cliff for the generic industry
The number of FDA inspections during 2014 of generic manufacturing facilities in India and China has continued to grow over previous years. At the same time the inspections have become more challenging and the regulatory expectations from inspections has continued to rise. Generic pharmaceutical companies are now investing in more IT equipment in their factories which allows the videotape recording of worker activities and IT systems which require higher management approvals for any changes to the protocols. However the number of new global generic companies entering the North American and European generic markets continues to rise each year as mid size generic companies from around the world seek to globalize their country footprint.
Individual generic trade associations in different countries are experiencing a fall in membership numbers as a result of these generic company mergers and acquisitions. In parallel the number of new members is rising from this globalisation trend.
In this issue we have a global portfolio of manuscripts from six individual countries (Jordan, Taiwan, Australia, Malaysia, India and Myanmar) as well as commentaries on Europe and USA generic issues.
Dr Brian W Tempest
Editor