Generics - February 2000 These conference papers examine strategies for developing generics within the lifetime of the innovator patent. The papers include details on Reimbursement policy, pricing, patent issues, regulatory changes, prescribing trends and strategies for growth. Keeping track of changes in the international market is proving a difficult task due to the rapid pace of change in national markets. Each country having specific regulatory, legal and market parameters is making generic entry increasingly more complex, these conference papers address these issues and much more. Please find 2 Executive Summaries from papers presented at IBC Life Sciences, Generics 2000 Conference. Please click on one of the below options to view the Executive Summary written from that presentation. Biotechnology Products, Russmann DL, PAREXEL-LOGOS Obtaining Approvals for Generic Products using EU Procedures For further information and details of the comprehensive documentation available from this event, please visit: www.ibc-lifesci.com/dy1154 1. Biotechnology Products, Russmann DL, PAREXEL-LOGOS [top] WILL "COMPARABILITY PROTOCOLS" ALLOW GENERIC BIOTECHNOLOGY PRODUCTS TO BE APPROVED AND MARKETED? Whereas analysts consider biotech products a major opportunity for the generic industry, many people maintain that there will be no generic biotech product at all in the future. According to the speaker's own opinion, biotechnology will be part of every future generic company's portfolio. There can be no doubt that the regulatory procedure for biotech has to be almost completely self-standing and cannot be covered by the wording of a "generic application". LEGAL FACTORS Essential similarity has been defined as "same qualitative and quantitative composition in terms of active principles (and excipients) and the pharmaceutical form is the same and where necessary appropriate bioavailability studies have been carried out". Marketing application for an essentially similar product, once registered in a EU Member State, is forced to undergo a Mutual Recognition procedure, or, if formerly registered by a MRP, to undergo a Centralised procedure. Exemption is made for drugs with well established use when using bibliographic application (ii) in case Member States have not been able to sufficiently harmonise the relevant SmPCs. WRITING EXPERT REPORTS FOR NATIONAL AND MUTUAL RECOGNITION PROCEDURES Expert Reports are the most comprehensive part of a Marketing Application dossier. Independently from the type of application (i, ii, iii) they are an obligatory part of any dossier for MA. Depths of work and format may differ depending on the individual needs, but the expert is strongly requested to meet the basic needs concerning structure, science and format. The examples presented by the speaker have been successfully submitted to various regulatory authorities. 2. Obtaining Approvals for Generic Products using EU Procedures [top] ... summary to follow soon ...