For biologics there is 12 years exclusivity starti
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Posted On: 12/12/2019 7:57:13 AM
Re: bwolfy2002 #12531
For biologics there is 12 years exclusivity starting from the time the drug is first approved for the first indication. That exclusivity period does not extend for new indications. That's why saying that we should focus on HIV rather than start up trials for other indications is nonsense.
For the USMCA trade agreement - without any agreement in place for exclusivity it would revert back to the country's laws. For Canada there's an 8 year marketing exclusivity. For Mexico there's a 5 year data exclusivity.
The current market in Latin America in dollars is currently less than 3% of the U.S. In Mexico the controls to ensure biosimilars are the same as the original are not as stringent as those in the U.S. so it might not be recommended to go there after the 5 year limitation expires.
For the USMCA trade agreement - without any agreement in place for exclusivity it would revert back to the country's laws. For Canada there's an 8 year marketing exclusivity. For Mexico there's a 5 year data exclusivity.
The current market in Latin America in dollars is currently less than 3% of the U.S. In Mexico the controls to ensure biosimilars are the same as the original are not as stringent as those in the U.S. so it might not be recommended to go there after the 5 year limitation expires.
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