Biosimilars: A Viable Market - But When?

Countries covered: United States, Europe Providing… 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.

Additional Information

The promise of profits from biosimilars grows greater, but only when a number of significant market, regulatory and clinical hurdles can be overcome. This critical 200-page management report addresses key issues of concern. Companies want profits, health payers want cost reductions and clinicians want efficacy.

Squaring the circle will take some doing.

The biosimilar sector continues to attract huge interest and controversy. Most generic manufacturers are actively involved in it, either directly or indirectly. The successful ones will be those with the patience, resources and above all money to invest now, in order to gain in the future. Even for the vanguard, however, those gains are some years off.

Reimbursement: How will payers treat biosimilars? Ideally for generic manufacturers they will regard them as therapeutically equivalent and therefore substitutable by pharmacists, in countries where this is an option. Originator companies want to see the opposite, where biosimilars are regarded as different products and therefore not substitutable. This is a major reason for the recent arguments regarding INN naming, since products with different INNs are less likely to be regarded as interchangeable. This issue is one for national healthcare systems and currently remains unresolved.

Will physicians prescribe biosimilars?
In countries with high generic usage, and where physicians are trained to prescribe by INN, prospects are theoretically good, the issue of different INNs notwithstanding. In the UK, for example, around 80% of prescriptions are written by INN. The overriding issue for physicians is going to be safety and efficacy; they need to be confident about a new drug’s capabilities in order to switch. But the likelihood of their doing so without some financial incentive is less certain. Physicians prescribe generics in order to save money, either from their own drug bill or that of the patient. It is not clear whether biosimilars will offer enough of a saving in this regard.

Will patients accept biosimilars?
In countries where generics are widely-used, patients should have little problem with properly approved biosimilars, although they are likely to want the latest drug available, if it is affordable. Many of the conditions treated by the drugs in this report are serious and require hospital administration, which allows less opportunity for ‘shopping around’. Products which are administered on a long term basis require more patient input. Biosimilar insulin, for example, may be able to save patients a lot of money over time, although they might prefer to spend more on a newer product which has to be injected less often or not at all.

Interchangeability and substitutability
A key point for developers of biosimilars is the issue of interchangeability. This is going to be a hard sell in regulated markets. Much of the legislation before Congress in the USA contains specific provisions which allow applicants to try to demonstrate this, but the FDA currently takes a dim view of the idea. In Europe, the biosimilar pathway speaks of ‘therapeutic similarity’ and leaves it at that. Issues of reimbursement are left to individual member states. There is little public sign that governments have begun to address the issue.

A step further is substitutability, i.e. can the hospital pharmacist provide a biosimilar version if the physician has prescribed the original. Or, going further still, can insurers mandate substitution for prescriptions they are paying for? This is extremely unlikely to occur, even in countries which have a generally pro-generic outlook. Countries such as France, the Netherlands and Spain, for example, have explicitly stated that biosimilars will not be substitutable, while the UK government has indicated that it does not expect substitution to occur.

For a thought-provoking, well argued and cost-effective management analysis on this critical generics sector, make sure you order this report today.

Who’s doing what, and with whom? Leading players assessed…
Abraxis BioScience
Anhui Anke Biotech
Barr Pharmaceuticals
Bioclones
Biocon
BioGeneriX
BioPartners
Bioton S.A.
Cangene
Cell Therapeutics
CIGB (Cuba)
Cipla
CheilJedang (CJ Corp)
Claris Lifesciences
Dr Reddy’s
Dongbao Biopharmaceutical
Dragon Pharmaceuticals
GeneScience Pharmaceuticals
GTC Biotherapeutics
Hospira
Inno Biologics
Insmed
Intas Biopharmaceuticals
Itero Biopharmaceuticals
LG Life Sciences
Marvel Lifesciences
Momenta Pharmaceuticals
NCPC Genetech
Pliva
Ranbaxy
Reliance Life Sciences
Sandoz
SciGen
Shantha Biotechnics
3SBio
Shenzhen Kexing Biotech
Stada Arzneimittel
Teva Pharmaceuticals
Three Rivers Pharmaceuticals
Viropro
Wockhardt
Zenotech Laboratories

More Europe Drug Discovery Reports

Analysis of the European Multiple Sclerosis Market by Frost & Sullivan
The Research Service aims to analyse and assess the European market for Multiple Sclerosis. This is performed by analysing the key trends and dynamics shaping ...

European PCR Reagent Market for Research Applications and Clinical Diagnostics by Frost & Sullivan
This research examines the European PCR reagent markets for research application and clinical diagnostics in terms of the challenges faced by market participants and drivers ...

Personalised Medicine Market in Europe by Frost & Sullivan
The following 44 slides provide an analysis of key trends and issues of the personalised medicine industry globally with a key focus on issues pertaining ...

Prostate Cancer - Italy Drug Forecasts and Treatment Analysis to 2020 by GlobalData
Prostate Cancer - Italy Drug Forecasts and Treatment Analysis to 2020 Summary GlobalData's pharmaceutical report, “Prostate Cancer - Italy Drug Forecasts and Treatment Analysis to 2020”. The ...

Prostate Cancer - Spain Drug Forecasts and Treatment Analysis to 2020 by GlobalData
Prostate Cancer - Spain Drug Forecasts and Treatment Analysis to 2020 Summary GlobalData's pharmaceutical report, “Prostate Cancer - Spain Drug Forecasts and Treatment Analysis to 2020”. The ...

See all reports like this >>

More Europe Reports

A Comprehensive Study Of The UK Video Conferencing Equipment Market In 2010, Rating & Valuing Each Of The 30 Companies That Operate In Today's Market by Plimsoll Publishing Ltd.
The Plimsoll Analysis provides you with the most up to date and comprehensive analysis of the top 9 companies operating the market. It is ...

A Comprehensive Study Of The UK Tableware Market In 2010, Rating & Valuing Each Of The 166 Companies That Operate In Today's Market by Plimsoll Publishing Ltd.
The Plimsoll Analysis provides you with the most up to date and comprehensive analysis of the top 9 companies operating the market. It is ...

A Comprehensive Study Of The UK Surveyors & Valuers Market In 2010, Rating & Valuing Each Of The 943 Companies That Operate In Today's Market by Plimsoll Publishing Ltd.
The Plimsoll Analysis provides you with the most up to date and comprehensive analysis of the top 9 companies operating the market. It is ...

A Comprehensive Study Of The UK Subsea Engineering Market In 2010, Rating & Valuing Each Of The 142 Companies That Operate In Today's Market by Plimsoll Publishing Ltd.
The Plimsoll Analysis provides you with the most up to date and comprehensive analysis of the top 9 companies operating the market. It is ...

A Comprehensive Study Of The UK Structural Engineering Consultancy Market In 2010, Rating & Valuing Each Of The 300 Companies That Operate In Today's Market by Plimsoll Publishing Ltd.
The Plimsoll Analysis provides you with the most up to date and comprehensive analysis of the top 9 companies operating the market. It is ...

See all reports like this >>