Biosimilar & Biotechnology Medicine Development - Project Examples

Preparation and Submission of a Biosimilar Registration Application

Capital K was commissioned to review, prepare and submit a new biosimilar compound for registration in Australia. The project included development of the relevant documentation, including bridging comparability data against the Australian reference product, assembly of the Australian-specific Annex to the Risk Management Plans, and generation of the associated Module 1 documentation.

In-depth Regulatory and Market Access Training Program

In order to prepare a company for a potential foray into biosimilar commercialisation, Capital K was commissioned to prepare and run a program of comprehensive training modules, covering the science of biotechnology and biosimilars, the regulatory and reimbursement pathways, and the corresponding commercialisation strategies. Capitalising on one of Capital K's strengths, the program covered the history and development of biosimilars globally and in Australia, and a prediction of future trends in this space. Feedback across the various technical and commercial participants, including from senior management, was tremendously positive.

Modelling Biosimilar Market Impact

Capital K was commissioned by a major biotechnology medicine company to investigate the impact of a potential biosimilar competitor launch in Australia. The project included investigation and presentation of various scenarios modelling the regulatory, reimbursement and in-market effects of a biosimilar launch, both on the company's current products and their pipeline portfolio. In addition to preparing a written report describing the findings, Capital K facilitated a workshop to 'acid test' draft commercial options, resulting in the development of new and alternative strategies which were also presented to the company's senior management team.

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Biosimilar Product Development