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General

US Senate healthcare bill preserves biologicals exclusivity, but charges annual drugmaker fees

The recently released US Patient Protection and Affordable Care Act, H.R. 3590, will ensure that all Americans have access to quality, affordable health care and will create the transformation within the healthcare system necessary to contain costs.

The hurdles to biosimilars in Europe

The stage is set for the entrance of biosimilars into the healthcare market. Patents are near expiry on the first biopharmaceuticals and the global biosimilars market is predicted to be worth more than Euros 1.5 billion by 2015. However, development costs will be high, unlike with generic drugs, the time taken to develop biosimilars is long, and acceptance on the market is not guaranteed.

Hurdles to entering the biosimilars’ market

Yet more hurdles to entering the biosimilars’ market have been identified in a Reuters’ report. High development costs, complex manufacturing and legal hurdles are holding back generic drugmakers seeking to copy high cost biotech medications nearing the end of their patents.

Biosimilars’ hurdles in the US

Europe serves as a model for other countries looking to define their own regulatory approval criteria. However the opposing interests of biosimilar and innovative companies is resulting in delays to the development of biosimilars in the US.

Hurdles to biosimilars in Asia

Now that a clear regulatory pathway for marketing biosimilars has been established in Europe, will Asian companies enter the global biosimilars race? Asian manufacturers face the same obstacles as western-based drugs companies, but local factors add a further twist to the tale.

Highs and lows for biosimilars during 2009/2010

A lot has happened in the biosimilars’ industry during 2009/2010.

Is US Congress poised to hinder biosimilars market entry?

A proposal by US Democratic Representative Anna Eshoo included in the US House health reform bill, would give developers of innovative biomedical drugs 12 years of data exclusivity from generic competition, significantly extending their patent rights, writes Los Angeles Times columnist Michael Hiltzik. Ms Eshoo said her proposal would give original makers of biotech drugs adequate profit to discover new treatments without discouraging generic drugmakers from working on follow-on biologics.

Innovation over imitation: New FOBs technologies, players

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, tables are presented on new technologies for creating ‘biobetter’ follow-on biologics (FOBs) and potential ‘Big Pharma’ players in FOBs.

Innovation over imitation - How to deliver FOBs on the bottom line

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.

Innovation over imitation - Charting the FOBs landscape

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.