Biosimilars: A viable market - but when?

A thorough review of the latest regulatory situation in the USA, Europe and selected markets

An examination of products that are currently available for development:

• EPO
• HGH
• G-CSF
• Human Insulin
• Interferon

A review of key issues such as development costs and legal matters. Consideration of upcoming product opportunities. Examination of the factors such as pricing and clinician response. A review of the work of 42 companies actively developing biosimilar products.

The promise of profits from biosimilars grows greater, but only when a number of significant market, regulatory and clinical hurdles can be overcome.

The future of the pharmaceutical industry lies with biotechnology. Biotech drugs account for around 10-15% of the current pharmaceutical market, and the sector is outperforming the market as a whole in terms of growth.

The need for a settled market environment is essential if the growing number of products which will lose patent protection in the next 5 years can be exploited. However, progress is painfully slow and the focus is now on three critical issues.

US regulatory impasse

Wrangling between the FDA, Congress and vested interests and the continuing lack of a regulatory pathway for biosimilars in the USA is stifling market expansion domestically and globally. When this is resolved currently available biosimilar products will have a market of volume and value and competition will increase.

Product range expansion

The current products are specialist and treat relatively few conditions at high cost. However, second generation products, including monoclonal antibodies indicated for high value conditions with unmet clinical need, such as cancer, will be more attractive to manufacturers.

Clinical acceptance

Biological drugs are complicated, expensive products used to treat complex conditions. Given this, it may be difficult for manufacturers to persuade physicians to prescribe and use generic versions. In some countries, such as France or Japan, prescribing of chemical generics is relatively unpopular, so the task will be more difficult for biosimilars where worries over equivalence will be greater and less easy to counter.

How this pans out in the future is crucial for the whole market. When will a significant biosimilar market develop? Could an abridged regulatory process really benefit generic manufacturers? Is there a political will to change the status quo in the US? Will physicians be the final arbiters of the sector’s success? Biosimilars: a viable market but when? is a critical 200-page management report, published in September 2008 by leading generic industry publisher Espicom Business Intelligence which addresses these and other key issues of concern.