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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.

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.

Price/access expected to be major drivers for biosimilars uptake

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

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.

Pivotal clinical trials for etanercept biosimilars

Biosimilars of Amgen/Pfizer’s blockbuster arthritis drug Enbrel (etanercept), a fusion protein produced by recombinant DNA, are currently under development.

Biosimilar events from 2013 to 2015

During the period of 2013 to 2015, biosimilars has been increasingly on the agenda around the world.  Biosimilars are making steady progress, as can be seen by the increasing number of events, including approvals for biosimilars around the world [1].

Payers in US getting ready for biosimilars

Payers in the US are getting ready for the advent of biosimilars, according to a report published by biotech giant Amgen.

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