The drug approval process in India is not complex, although poor patent protection and government policies favoring generic companies make multinational companies (MNCs) wary of launching new drugs in the country.
Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market. These market leaders, however, face patent expirations and consequent biosimilar launches.
With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market.
The German generics industry is feeling the effects of recent efforts to control drug spending by exerting downward pressure on drug prices.
Data indicates that companies often favor Germany when choosing a reference member state (RMS) in order to gain approval under the decentralized procedure, perhaps reflecting overall a fast pace of regulatory review.
Continued growth in healthcare expenditure and the high number of individuals without health insurance coverage were the key drivers of the passage of the healthcare reform law.
Despite their high prices, Kadcyla and Perjeta are widely reimbursed in the US and have experienced fast uptake as payers have limited options for cost control in this indication.
This analysis covers the four major emerging regions of the Middle East and Africa, Latin America, Eastern Europe, and Asia-Pacific. Within these regions, relatively wealthier markets with a proven marketplace for orphan medicines have been prioritized.
The average drug price in Poland is the lowest in the EU, mainly due to the high proportion of generic pharmaceuticals, low availability of innovative drugs, and high price pressure on reimbursed drugs.
Follow-on biologics have been embraced enthusiastically in most emerging markets, where they promise to deliver much-needed improvements in access to a generation of products that remains beyond the reach of many patients.
The level of concern surrounding the budget impact of acute myeloid leukemia (AML) has traditionally been low due to the relatively small size of the population in comparison to solid tumors, the high severity of the disease, and a lack of branded treatment options. As a result, few access controls are utilized for AML therapies. […]
China has recently completed its 2009–11 healthcare reform. The reform has come at a high cost: although the Ministry of Health intended to invest CNY850bn ($135bn) in the plan, total investment has now exceeded CNY1,100bn ($175bn).
The German pharmaceutical market has historically been the most attractive European market due to high prices and high drug utilization. However, this is changing, with comparability assessment requirement raising the bar for achieving a higher price point.
A new value-based assessment (VBA) process is scheduled to come into effect in the UK in late 2014. There have been significant delays in determining how this would work in practice, reflecting VBA’s complexity.
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