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The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. Read More
Generic drug applications surged in December, with the FDA receiving 235 ANDAs — the second-highest submission record for a particular month since the implementation of GDUFA. Read More
The FDA responded to commonly raised questions about the 180-day exclusivity for generics in a draft guidance document covering everything from patents to forfeitures. Read More
The FDA rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on the agency’s naming scheme published earlier this month. Read More
The FDA will proceed with using a nonproprietary naming approach that relies on arbitrary four-letter suffixes to distinguish biosimilars and biologics, showing a disregard for industry concerns in a lightly tweaked final guidance that adds a few new considerations for suffix proposals. Read More
The European Parliament’s committee on Environment, Public Health and Food Safety voted to approve a draft report that includes dozens of recommendations for improving how the EU promotes access to medicine, prioritizes generics, and handles intellectual property, and pricing issues. Read More
The Office of Management and Budget clarified President Trump’s new “one in, two out” regulations order, narrowing its scope to significant regulations with an economic impact of over $100 million per year, and new guidance documents considered on a case-by-case basis. Read More
Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics (PK) and pharmacodynamics (PD). Read More