Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory assessment of registration processes for biosimilar products- Conditions to be fulfilled to use special registration procedures designed by different decision matrices ***

Gabriele Schäfer (Abschlußjahr: 2006)

Language: English

Within the next few years more and more biological products will run out of patent and generic competitors will enter the market with high quality biosimilar products. On the other hand branded companies try to defend this very profitable market, and as it is stated in an article of the Journal of Generic Medicines13) “The battle is only just beginning.”

Until the year 2003 the legal frame work for the registration of biosimilar products was not available, and generic competition in the field of biological products was not existent. At the beginning of the year 2006 the first two biosimilar medicinal products have been registered in the European Community.
The generic approach does not apply for biosimilar medicinal products as the active ingredients contained are very complex molecules.

As biosimilar products are mostly derived from biotechnological processes, they fall within the mandatory scope of the Centralized Procedure.

Development and registration processes of biosimilar products are very complicated. The tools provided by decision analysis enable the people involved in this process to choose the best way to register those products timely and as cost-effective as possible.

Therefore, when developing the registration strategy for a biosimilar product, it is absolutely mandatory to first make a situation appraisal to examine the whole situation in detail. The situation appraisal must be followed by a decision analysis to select the most appropriate registration strategy. When the decision has been taken, a risk assessment must be conducted in order to establish the implementation plan, prepare actions to address future problems, and constantly update and monitor the plan.

In case the Mother Company is the originator company for the biological product, informed consent registration is the best choice.

In case the reference medicinal biological product is owned by a 3rd party, the in-house development is preferred.

Early-entry is a special way to bring biosimilar products into the market. In case of an early-entry 2 opportunities exist. A duplicate of the reference product will be marketed, or the own in-house developed biosimilar is marketed before patent expiry with the informed consent of the branded company.

Biosimilar medicinal products are cheaper than the reference products marketed by the branded companies but they are more expensive than simple generic products.

The question is if the originator companies will lower their prices to the level of the biosimilar product? The answer to this question will depend on the number of biogeneric competitors on the market and the general acceptance of the biosimilar products by health care professionals and patients. A good lobbying will be the key to success.

Pages: 39,
Annexes (Tables): 17