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Reference products and toxicity studies for biosimilars in Japan

In his presentation, at the 14th Annual Biosimilars Group Conference, Dr Daisaku Sato, Director, Office of Cellular and Tissue-based Products at the Pharmaceutical and Medical Devices Agency (PMDA), discussed what reference products are acceptable and whether repeat-dose toxicity studies are required for marketing applications for biosimilars in Japan [1].

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.

Guidelines needed for follow-on versions of NBCDs

Currently, ‘follow-on’ versions of non-biological complex drugs (NBCDs), such as iron carbohydrates, liposomal drugs and glatiramoids, and which also include some synthetic proteins and polypeptides, are approved under the generics pathway.

Global uptake of biosimilars

About 85% of the human world population lives in an emerging economy, where biosimilars are less-regulated or even unregulated. Taking into account the huge cost of originator biologicals, and with the growing affluence and purchasing power in these emerging countries, the market for biosimilars is expected to grow significantly in these regions for the foreseeable future.