• Biopharmaceutical Classification System (BCS) Biowaiver Assessment & Report; A unique service

    Problem Statement

    Often, competent authorities do not accept BCS biowaiver claim on a test product but insist on carrying out Bioequivalence studies to confirm safety & efficacy comparable to the brand product. The main reason is failure to comply with competent authority guidelines.

    Alternatively, Biowaiver is often thought of too late in the application stage and thus pharmaceutical companies do not have time to consider the relevant guidelines. 

    Who would consider applying for BCS Biowaiver?

    To avoid carrying out Bioequivalence studies, the company should consider applying the BCS based biowaiver approach at early stage of product development. The BCS Biowaiver, if successful, will save time, effort and money at a fractional cost of carrying Bioequivalence study.

    What can be done?

    OnTarget Pharma Consultancy (OTP) is offering this unique service. By reviewing the products’ attributes against the brand, the level of compliance with the guidance requirements could be determined and advice given on its eligibility. A Biowaiver Assessment report (BAR) will be complied that analysis the test products’ features against that already licensed product.

    How it is done?

    The report will discuss the BCS classification of the drug substance and how it can be determined as per the current guidance requirements and expectations. Further and depending on the BCS classification of the DS, revision of the test product regarding formulation, composition, versus the brand will be carried out. Also, the requirements for dissolution profile comparisons versus the brand to ensure compliance with the current guidance for BCS Based Biowaiver will be discussed and highlighted. 

    The BAR will discuss and analyse the provided information in its entirety, taking into consideration the data available in the public domain. Such data includes the SPC of the brand, BCS classification of the DS and how the information is related to the project. This information directly affects the speculation with regard to eligibility of the test product for the BCS biowaiver. Against each factor considered in the report, its level of relevance and risk will be evaluated. Risk factor attribute scoring allow the client to priorities appropriate risk attributes suitable for their product.  

    If interested, please write to muhaned@ontargetpharma.com  providing name and details of contact for further discussions. Upon request, a free preliminary Biowaiver assessment can be offered.