CRED 8 Presentations

03/07/2024

Timing to submit a generic or biosimilar MA application

Reference product is protected in two ways bearing in mind the statement that the generic product requirements should be ‘without prejudice to the law relating to the protection of industrial and commercial property ’ and ‘ ensuring that innovative firms are not placed at a disadvantage’

1. Patent (including supplementary protection certificates)

2. Data exclusivity

The Organisation for Professionals in Regulatory Affairs

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Patents

Patent Protection • Patents granted to the innovator on the molecule/formulation/process /indication to protect commercialisation of the product by someone else prior to patent expiry • refers to an exclusive right to prevent others from exploiting an invention without the patentee’s consent Supplementary Protection Certificate (SPC) • Supplementary protection certificates were introduced to compensate for the long time needed to obtain regulatory approval of medicinal products • Offset the loss of patent protection

• Applied in individual MS • Up to 5yrs exclusivity

Neither are taken into consideration by Regulatory Authorities regarding assessment

The Organisation for Professionals in Regulatory Affairs

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