Reports

Achieving international regulatory convergence for biosimilars

Home/Reports | Posted 04/11/2016

In the 2000s both the European Union and the World Health Organization (WHO) published biosimilars guidelines. Since then, major regions have developed and adopted guidelines based on WHO’s standards for similar biotherapeutic products. Agencies that have now implemented biosimilars guidelines include Australia’s Therapeutic Goods Administration (TGA), Health Canada, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and Drug Administration (FDA).

FDA says trust and education critical for biosimilars

Home/Reports | Posted 21/10/2016

The US Food and Drug Administration (FDA) has highlighted trust and education as critical factors in ensuring patient access to biosimilars.

Extrapolation of indications for biosimilars in Japan

Home/Reports | Posted 14/10/2016

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 extrapolation* of indications for biosimilars in Japan [1].

Potential cost savings from use of biosimilars in the UK

Home/Reports | Posted 14/10/2016

A new report into the use of biological therapies to treat inflammatory bowel disease (IBD) has found that biosimilars are safe and effective for patients and if adopted can halve the cost of treatment in the UK.

Naming and interchangeability for biosimilars in Japan

Home/Reports | Posted 07/10/2016

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 naming rules and interchangeability for biosimilars in Japan [1].

Reference products and toxicity studies for biosimilars in Japan

Home/Reports | Posted 30/09/2016

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

Home/Reports | Posted 23/09/2016

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

Home/Reports | Posted 05/08/2016

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

Home/Reports | Posted 01/07/2016

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

Home/Reports | Posted 24/06/2016

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?

Home/Reports | Posted 10/06/2016

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

Home/Reports | Posted 03/06/2016

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

Home/Reports | Posted 27/05/2016

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

Home/Reports | Posted 25/10/2013

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

Home/Reports | Posted 03/08/2012

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.

Spending on medicines in the US increases again in 2015

Home/Reports | Posted 20/05/2016

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

Home/Reports | Posted 13/05/2016

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

Home/Reports | Posted 06/05/2016

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.

Price/access expected to be major drivers for biosimilars uptake

Home/Reports | Posted 29/04/2016

Payers in the US expect price/access to be the major drivers for biosimilars uptake, according to a report published by biotech giant Amgen.

Pivotal clinical trials for infliximab biosimilars

Home/Reports | Posted 11/09/2015

Biosimilars of Johnson & Johnson’s blockbuster arthritis drug Remicade (infliximab), a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α), are currently under development.