According to the results of an exclusive on-line survey conducted by Drug Topics, an overwhelming majority, pharmacists support a pathway for follow-on or generic biologics.
By an overwhelming majority, pharmacists support a pathway for follow-on or generic biologics. According to the results of an exclusive on-line survey conducted by Drug Topics, 29% of the 208 respondents said that they believe biogenerics should be approved, and, if they were, the result would mean reduced healthcare costs. Almost half (49%) said that they support biogenerics but only if they pass the same testing that the original brand-name products went through. Twelve percent of the respondents said Europe has already approved some biogenerics, so U.S. should too. Only 4% said they did not approve of follow-on biologics because they have not proven to be comparable to their reference products, while 1% said that biogenerics would hurt brand-drug research. Five percent of the respondents said that they didn't know if biogenerics should be approved in the U.S.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.