Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Reclassification of Insulin products from drugs under FDC Act to biologics under PHS Act after March 23, 2020 and its impact on product development related to CMC dossier contents also with regards to registration of "Follow-on" Insulins and comparison with other major markets

Franziska Köthe (Abschlußjahr: 2019)

Summary
The actual Master‘s thesis outlines the heterogeneous regulatory framework for submission of Insulin products in the major markets EU, CA and US. Situation might be founded in different appreciation for therapeutic proteins of a minor size and complexity to be regarded as biological products. Diabetes is one out of the five highly spreaded non-communicable diseases with a high prevalence and limited access to Insulin even in high income countries like US. Individual and public healthcare costs increase every year.
In 2010 the Public Health Service Act enacted an abbreviated regulatory pathway under section 351(k) to enable development and market access for biosimilar products, comparable to "Hatch-Waxman Act" of 1984, for cost savings and unlimited access to lifesaving medicines. After a transition period of 10 years, Insulins will become biologics on March 23, 2020.  Currently in US insulin products are regulated as drugs approved under section 505 of the FDC Act and not as biological products under section 351 of the PHS Act, although that they fulfill the definition of a biologic and are registered as biologics in other major markets like Canada or EEA. FDA plan to reclassify these products after March 23, 2020 as Biological Products. Approved applications for insulin products under section 505 of the FDC Act "shall be deemed to be a license for the biological product under section 351 of the PHS Act." This transition and the impact on product development related to CMC dossier contents are regarded.
Different from small molecules, manufacturing of biologics is quite complex and requires highly process related knowledge. Therefore it is questionable, whether new manufacturers would be able to rapidly enter the market as for generics. In addition definition and requirements to be fulfilled to develop a product that is highly similar or interchangeable to a reference product licensed under section 351(a) PHSA.
Pages: 56   Annexes: 4 pages 9