European Union biopharmaceuticals

There are at present about 165 biopharmaceutical drugs approved for marketing in the United States and the European Union. This market is worth more than US 50 billion, projected to reach US 70 billion by 2010. Approvals in the past 3 years are mainly for monoclonal antibodies, enzymes, and growth factors. 

The development and regulatory approval of biopharmaceuticals in the European Union (EU) has lagged slightly behind that in the United States. But... 

TABLE 41 Examples of biopharmaceuticals approved In the European Union... 

Centralized Procedure (CP) This is the procedure of most interest for biopharmaceuticals, as this is the mandatory route for review and approval of such drugs in the European Union. In the centralized procedure a single application is submitted to the European Medicines Agency (EMEA). A variety of presubmission activities, starting six months before the intended start date of the centralized procedure, are required [8], Two initial assessments by a Rapporteur and Co-rapporteur national authorities (one from each of two member states chosen by the EMEA) are made, leading to Day 80 Critical Assessment Reports. A consolidated list of questions (LoQ) is provided to the applicant at Day 120 when there is a clock stop, normally of three months, to allow the preparation and submission of responses. Following satisfactory negotiation of other steps in the procedure, the Committee on Human Medicinal Products will recommend authorization at Day 210, with authorization by the Commission at Day 277. 

The major difference between application of the ICH S6 guideline in the European Union, compared to the United States and Japan, is the rather more complex interaction with the regulatory agencies in relation to agreeing on the preclinical testing strategy for biopharmaceuticals. While sponsor compa-... 

As a result of the national scope of many intellectual property laws, problems sometimes develop where inventions, such as biopharmaceuticals, are traded internationally. International trade can bring divergent national legislation into conflict. Countries that are net exporters of innovations protected by IPRs, such as the United States, the European Union, and Japan, advocate strongly in the international arena for the strengthening of national intellectual property laws and international harmonization of these laws [46]. Although international harmonization... 

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