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Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Abridged applications (line extensions and generics)

BioVentures Consulting Limited views line extensions and generic applications as a sub-set of abridged applications. These are applications for which a full toxicology and pharmacology package; and clinical trials do not have to be provided for successful authorisation for a medicinal product since it is essentially similar to one which is already authorised. Often this is a matter of judgement, and requires a combination of both experience and expertise to determine the most appropriate life-cycle strategy. In this regard BioVentures Consulting Limited can be a valuable partner in helping to advise on the most suitable product life-cycle development strategy.

BioVentures Consulting Limited can help with strategies which maintain the life of a product in the face of pending generic competition

Such strategies may involve products with a well-established use (requiring scientific bibliography and a licence application based on a Quality package); an informed consent application where the MAH may allow use to be made of the pharmaceutical, preclinical and clinical documentation contained in the file to another party (via cross-referencing) for another product in a different livery; generic applications where "essential similarity" is shown through bioequivalence and bioavailability studies; a hybrid application strategy, which is similar to a generic but with a difference to the reference product (such as a change in the active substance, therapeutic indication, pharmaceutical form, strength or route of administration); a "biosimilars" strategy where the biological medicinal product does not match the reference biological product (e.g. due to a different manufacturing process or raw materials); fixed combination applications, where authorised products have not been used in combination for therapeutic purposes (requiring the need for new preclinical or new clinical trials relevant to the proposed combination); or line extensions, which involve a change to the existing marketing authorisation to the extent that it is considered a new MA rather than as a variation.

These may involve changes to the active substance or to the product presentation (such as the strength, pharmaceutical form and route of administration).

If applied correctly, such strategies can provide data exclusivity, patent and market protection for originator pharmaceuticals during a period of exclusivity. BioVentures Consulting Limited can help with strategies which maintain the life of a product in the face of pending generic competition, and in the development of generic programmes. This includes advising on the reference medicinal product, the quality, pharmaceutical form and bioequivalence studies. It can help construct the Summary of Product Characteristics (SmPC) and advise on the timing of the submission. These aspects can be important due to changing market conditions, the rapidly-growing emerging markets with different regulatory philosophies and different ICH regulatory systems.

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