A generic drug is considered an exact copy of an already existing authorized drug product. On the other hand, a hybrid drug differs in some ways from its reference product while still being based on data from the same. Biosimilar is a term for a product similar to an already approved biological product.
The challenging part with abridged applications is often that you must plan what to do to fulfill the regulatory requirements from a regulatory perspective and simultaneously make sure to work fast as you compete with other companies for approval and market shares.
How we help
- Target product profile to define goals and requirements to be fulfilled
- Gap analysis and due diligence of dossiers
- Regulatory roadmap to provide advice on the legal basis for market authorization (section 505(j) generic, 505(b)(2) hybrid and 351(k) biosimilar in the US and article 10(1) generic, 10(3) hybrid and 10(4) biosimilar in EU) including recommended strategy for the non-clinical, clinical and quality data packages.
- Scientific advice meetings with FDA, EMA, and EU national authorities.
- Preparing and compiling the eCTD documentation and management of the market authorization application until opinion.