๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐
The approval timeline for a biologic can vary depending on the complexity of the product and the data required to support its safety and effectiveness.
๐ฃ๐ฟ๐ฒ-๐๐ก๐ ๐ฑ๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐: 1-2 years
๐๐ก๐: 1-2 years
๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐ฎ๐น๐: 3-7 years
๐๐๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป: 6 months
๐๐๐ ๐ฟ๐ฒ๐๐ถ๐ฒ๐: 6-12 months
๐ง๐ผ๐๐ฎ๐น ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ถ๐บ๐ฒ: 5-10 years
๐๐ถ๐ผ๐๐ถ๐บ๐ถ๐น๐ฎ๐ฟ๐
The approval timeline for a biosimilar is typically shorter than the timeline for a biologic because biosimilars do not need to undergo the same extensive clinical trials.
๐ฃ๐ฟ๐ฒ-๐๐๐ ๐ฑ๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐: 1-2 years
๐๐๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป: 6 months
๐๐๐ ๐ฟ๐ฒ๐๐ถ๐ฒ๐: 12 months
๐ง๐ผ๐๐ฎ๐น ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ถ๐บ๐ฒ: 3-4 years
๐ก๐๐
The approval timeline for a new drug application (NDA) can vary depending on the complexity of the product and the data required to support its safety and effectiveness.
๐ฃ๐ฟ๐ฒ-๐๐ก๐ ๐ฑ๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐: 1-2 years
๐๐ก๐: 1-2 years
๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐ฎ๐น๐: 3-7 years
๐ก๐๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป: 6 months
๐๐๐ ๐ฟ๐ฒ๐๐ถ๐ฒ๐: 12 months
๐ง๐ผ๐๐ฎ๐น ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ถ๐บ๐ฒ: 5-10 years
๐๐ก๐๐
The approval timeline for an abbreviated new drug application (ANDA) is typically shorter than the timeline for an NDA because ANDAs rely on the safety and effectiveness data of the reference product.
๐๐ก๐๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป: 6 months
๐๐๐ ๐ฟ๐ฒ๐๐ถ๐ฒ๐: 12 months
๐ง๐ผ๐๐ฎ๐น ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ถ๐บ๐ฒ: 1.5 – 2 years
Please note that these are just estimates, and the actual approval time for a product may vary. The FDA can also expedite the review process for certain products, such as those that are intended to treat serious or life-threatening diseases. Also, N/A for Biosimilars is mentioned to denote no specific time frame is available.
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Related: Amit Singh