The regulatory challenges and innovations in peptides with Dr Renata Varga

We spoke to Dr Renata Varga, Scientist - Characterization, Analytical Sciences, Global Biolodical CMC, Teva Pharmaceutical, about the regulatory challenges peptide developers face today as well as the innovations she expects to see in the next five years.

What are the key regulatory challenges that peptide developers face today?

'The biggest challenge is the lack of any guidance specific for peptides. There are many guidelines for small molecules and for large biomolecules as well, but almost nothing for peptides. Peptides are somewhere in between small molecules and biologics, but rather excluded from both guiding documents. In one hand it gives more flexibility to the sponsors to present their data but also a risk
of not knowing what is really needed and enough to present to get approval.

However there is some progress recently: more and more peptide-specific conferences and meetings are called, where regulatory agencies presence increased and publication of case example documents are also helpful, such as the one published by FDA about the demonstration of similarity between Copaxone and a
generic, just approved.'

What do regulators look for when establishing CQAs in generics, and do the criteria vary between generics and novel therapeutics?

'First of all, I don’t think there is any difference between novel therapeutics and generics in this perspective. CQA assessment is part of the QbD development what is encouraged and somehow expected by the agencies nowadays. But the reason for assessing the critical quality attributes is not only to fulfill an expectation, but also because it serves as a better understanding of the product under development.

It’s rather a scientifically designed and justified guidance for the whole development, including manufacturing process design and controls, identifying the sensitive residues of the molecule, establishing the right characterization and comparability approach and setting specification as a final control. I do believe that regulators are looking for that deep understanding of the whole procedure and the molecule itself behind the execution and provided data, which might make them more confident about the quality, efficacy and safety of that submitted generic product.'

Where do you see innovation happening in the peptide field over the next 5 years?

'I think more and more companies start to develop generic peptides, which results in a bigger competition, but it also triggers agencies to come up with regulations and guidance. And as I already said more and more conferences or meetings are organized specifically for peptides where sponsors can present their work and the agency representatives might give some insight into their thoughts.

I do believe that due to the increasing number of peptide submissions, available data on file reviews, questions coming back from the agencies and communications between sponsors and agencies everybody will have a better understanding how to develop generic peptides and it won’t be as a grey area as now.'