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Regulation of biosimilars in Japan

Biosimilar regulations, based on the European Union’s existing processes, were issued by Japan’s regulatory body for the approval of medicines, the Ministry for Health Labour and Welfare (MHLW), in March 2009 [1]. The MHLW’s regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), provides consultations concerning the clinical trials of new drugs and medical devices and handles biotechnology medicines, including biosimilars.

Saving money and building trust in biosimilars

The increasing cost of medicines was highlighted at the Biosimilar Medicines Group (formerly EBG) satellite symposium at the European Association of Hospital Pharmacists 2016 conference [1].

Global generics market expected to grow

A report on the global generics market forecasts that the market will grow at a compound annual growth rate (CAGR) of 10.53% during the period 2016–2020.

Half of doctors not convinced about biosimilars

A survey of doctors carried out by SERMO, a global social media network, has found that half of doctors do not feel that they have enough educational information to prescribe biosimilars to their patients.

How are biosimilars important for patients?

In its new Biosimilars Handbook, industry association Medicines for Europe (previously the European Generic medicines Association) describes how biosimilars are important for different groups.

Medicines for Europe launches Biosimilars Handbook

In February 2016, Medicines for Europe (previously the European Generic medicines Association) released the Biosimilars Handbook.

South Korean pharma market to reach US$20 billion by 2020

The pharmaceutical market in South Korea is on the increase and is expected to reach more than US$20 billion by 2020.

Spending on medicines in the US increases again in 2015

Growth in spending on medicines in the US increased by US$46.2 billion, or 12.2%, over 2014 levels, reaching US$425 billion in 2015. The increase was fuelled by the number of new medicines launched (43 new active substances were launched in 2015), while the savings from brand-name drugs facing generics competition were relatively low.

Payers in US expect biosimilars to reduce costs

Payers in the US expect the use of biosimilars to be a strategy that can be used to reduce the cost of specialty drugs, according to a report published by biotech giant Amgen.

Prices of brand-name drugs in the US have doubled since 2011

According to Express Scripts, the average price of brand-name drugs in the US has doubled in the past five years and has increased on average by 16.2% since 2015. Express Scripts, the largest pharmacy benefit management organization in the US, based its March 2016 report on prescription use data for members with drug coverage by the organization.

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