Analog preparation
An analog preparation , often also called me-too preparation , is a drug that contains a drug that has no or only marginal therapeutic differences compared to a drug introduced earlier .
Medicinal products that contain medicinal substances that lead to a relevant improvement in the pharmacodynamic or pharmacokinetic properties of already known active principles are not counted among the analog preparations.
Drug structure
Analog preparations contain new drugs which, compared to existing drugs, show a slightly different molecular structure . They should not be confused with generics , which contain active ingredients that are identical to the original product.
Emergence
Analog preparations are either brought onto the market by the manufacturer of the original drug as a further development, with the new active ingredient being patentable again due to the new molecular structure , or they are developed by a competing company. On the one hand, the competing developments can be development programs that were carried out at the same time but ended later; on the other hand, gaps in the original patent can be exploited in a targeted manner in order to be able to bring a product to the market in the same product class. Such products are also called me-too preparations in the narrower sense (English Me too = me too).
Share of newly approved drugs
In 2006 a total of 27 new drugs were approved. Of these, only two were clearly classified as analog preparations, two more were not clearly classified. All other drugs were classified as innovative. In previous years, the proportion of new approvals classified as analog preparations was significantly higher.
Therapeutic benefit
The added value of analog preparations is controversial. While the pharmaceutical industry speaks of important step innovations , health insurances and politicians as well as the drug prescription report criticize these drugs as pseudo-innovations that bring no or only insignificant additional benefit and are therefore only brought onto the market in order to secure market shares or to comply with legal regulations To bypass the price reduction of drugs.
A differentiated presentation of the evaluation of drug innovations can be found in a position paper of the German Pharmaceutical Society. The company warns against dismissing all active substances following the lead substance of an active substance class a priori as merely imitative "me-too preparations". The vast majority of the currently most prominent drugs were created through step innovations.
refund
Due to their controversial benefits, analog preparations are the target of statutory savings measures. In Germany , patent-protected analog preparations that do not bring about any therapeutic improvement or reduced side effects have been included in the second fixed-price group since the GKV Modernization Act (GMG) that came into force on January 1, 2004 . People with statutory health insurance have to pay amounts for such drugs that exceed the fixed amounts themselves, even if there is an exemption from co-payment.
See also
Individual evidence
- ↑ U. Fricke, W. Klaus: New medicines: facts and reviews from 2002 to 2005 approved medicines, Vol. 16 ISBN 978-3804723245
- ↑ Drug Ordinance in Practice 2/2007 (PDF)
- ↑ Criteria for assessing drug innovations (PDF; 458 kB)
Web links
- Ulrich Schwabe: Patent-protected analog preparations (Me-too list 2016) (PDF)
