Case Study Of Target Product Profile (TPP)

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The goal of each pharmaceutical company is to develop drug product and get marketing authorization approval. It changes the life of the patients by giving better life. When a company is planning a drug development journey it should have clear thoughts how new product will improve the patient’s life compare to available products in the market or in the pipeline. A Target Product Profile (TPP) is very helpful assistance in recognizing the chosen product characteristics and interactive them to the drug progress team, stakeholders, and regulatory establishments. The drug development process is very lengthy and expensive .TTP facilitates the complicated path which ending with FDA approval by proving all drug related scientific and medical information. The FDA has established draft guidance in 2007 concentrating on the use of Target Product Profile as a drug development tool to improve interactions between the sponsor and the FDA throughout all steps of the drug progress process.
Target Product Profile
Drug Product
Rituximab is a one kind of a monoclonal antibody drug class established by investigator Nabil Hanna and colleagues at IDEC Pharmaceutical as an IDEC-C2B8 target and attached to protein CD
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Rituximab, an anti-CD20 mAb has introduced in the market more than a decade intended for the treatment of many B-cell sicknesses. The Hatch-Waxman Act encourages generic competition (Biosimilar) to make available biologic for larger population by reducing drug cost. Biologics product can obtain patent protection lasting for 20 years from the date the patent application, so hard to make biosimilar. In year the 2006 the EU has approved the first Biosimilar while in 2009, the Biological Price Competition and Innovation Act (BCPI) was created for Biosimilars and signed into law on March 23, 2010 through The Patient Protection and Affordable Care Act (Affordable Care

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