Question
On February 28, 2022, FDA approved the biological drug CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after
On February 28, 2022, FDA approved the biological drug CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Your company is interested in developing a Biosimilar Drug for CARVYKTI, based on this approval. As a Regulatory Affairs Professional, how would you advise your company to ensure the biosimilar product is developed on time and would be prescribed by healthcare providers?
Step by Step Solution
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Step: 1
As a Regulatory Affairs Professional I would advise the company to take the following steps to ensure the timely development and healthcare provider a...
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Business Ethics A Stakeholder And Issues Management Approach
Authors: Joseph W. Weiss
7th Edition
1523091541, 978-1523091546
