Faced with the mounting burden of rising pharmaceutical costs and a rapidly ageing population, European governments are under immense pressure to implement corrective measures. Several countries have resorted to methods such as generic substitution and reference pricing to lower pharmaceutical pricing.
In addition, some countries are offering incentives to pharmacists and physicians to prescribe generics - a trend that will have a considerable impact on the generics market. The advent of biosimilars is also projected to a key factor in pushing down drug prices.
However, disparate country-specific policies regarding generics are causing significant variations in market development. Generics manufacturers confront further hurdles such as EU accession, lack of Roche/Bolar provision and delay in marketing authorisation applications.
"Although EU accession is believed to provide long-term benefits to generics manufacturers, policy harmonisation is expected to take a few years," explains Mr. Kambhammettu. "In addition, the lack of provisions such as the Roche/Bolar provision, which allows for research to be carried out before the loss of patent exclusivity, will delay generic approvals in Europe."
To succeed in a highly competitive environment and accelerate their time-to-market, participants should leverage the potential of low-cost contract manufacturing markets such as India and China. Strategic agreements between companies operating in different countries will also yield synergistic benefits. Finally, efforts must be directed to optimising product portfolios and devising long-term R&D strategies.
