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Biosimilars: A viable market - but when?
Espicom Business Intelligence Ltd, Sep 2008, Pages: 210
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
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