The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.
A pilot program that will see the US Food and Drug Administration and European Medicines Agency provide parallel scientific advice on complex generics and hybrid medicines to prospective applicants has been announced by the two regulators.
“This pilot program is an expansion of FDA and EMA’s existing PSA for new drugs and biological products,” the FDA...
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The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.
Aurobindo is confident its planned Lannett acquisition will pass US FTC scrutiny after an attempt to acquire Sandoz assets was called off in 2020 post a delay in approval. The deal could widen Aurobindo’s US manufacturing presence at a time when its US Q1 revenue saw a year-on-year decline.
While biosimilars have seen success in Europe, there are still plenty of areas in which policy improvements could solve problems for the market, according to a new Samsung Bioepis white paper. Adam Levysohn, the firm’s local head of commercial strategy, talks about the proposals.
Denosumab, aflibercept and ustekinumab biosimilars received positive opinions from the EMA’s CHMP at its meeting in July, along with an Opsumit generic from Accord.
At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.
