Drug companies have made comments on FDA’s draft guidance for industry on formal meetings between the agency and biosimilars manufacturers. They believe that the guidance needs some revision to protect data and provide clarity.
The guidance document was issued by FDA on 1 April 2013 and comments were due by 31 May 2013. The aim of the guidance is to assist sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products [1].
The guidance establishes five different types of meetings to be used at various points in the development cycle of a biosimilar:
- Biosimilar initial advisory meeting – to discuss whether the 351(k) biosimilar pathway is feasible for a given product and, if so, give general advice on the expected content of the development programme. These meetings should occur within 90 days of FDA receiving a request from a sponsor.
- Biosimilar product development (BPD) Type 1 meeting – to discuss clinical hold, special protocol assessments, important safety issues or resolve disputes.
- BPD Type 2 meetings – to discuss a specific issue to allow FDA to dispense targeted advice.
- BPD Type 3 meetings – in-depth data review and advice meeting regarding an ongoing BPD programme.
- BPD Type 4 meetings – to discuss the format and content of a biosimilar application or supplement.
Need for clarity
Comments on the guidelines from US industry body the Generic Pharmaceutical Association (GPhA) focused on the need for clarification with respect to FDA’s expectations and requirements, the timelines within which sponsors could expect to receive feedback and whether a request for an initial biosimilar advisory meeting could be denied and if so under what circumstances.
Generics giant Teva Pharmaceutical Industries (Teva) agreed with the GPhA in the need for further details and clarity, specifically in the areas of the amount of data necessary for FDA to grant an initial advisory meeting and the amount of information and data necessary to support a BPD Type 3 meeting. Teva also thought its necessary to include information on the internal FDA process for reviewing meeting background packages for biosimilar products in development.
Boehringer Ingelheim Pharmaceuticals also commented on the lack of clarity regarding FDA’s timelines in the draft, saying they ‘are too protracted and complicate the agency’s advice to sponsors to have a step-wise approach to biosimilar development’.
Generics manufacturer Apotex also requested clarity regarding whether the five types of meetings had to be carried out in sequence and whether the initial meeting was always necessary. The company also called for transparency regarding FDA’s review process as a way of justifying ‘why it takes FDA such a long time to grant the specific requested meeting(s) and the preliminary feedback prior to the scheduled meeting.’ Apotex also expressed concerns that the pathway would not be an abbreviated one based on the ‘extensive amount of information that FDA has requested to be included in the biosimilar package’.
Drug manufacturers also used the comments to push for clarity on biosimilar user fees, with generics company, Mylan, arguing that the fees should be lower than those paid for originator drugs under the requirements of the Prescription Drug User Fee Act (PDUFA).
Related article
US guidelines for biosimilars
Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance for biosimilar meetings [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 14]. Available from: www.gabionline.net/Guidelines/FDA-issues-draft-guidance-for-biosimilar-meetings
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