Generics Bulletin reviews global regulatory developments across the world.
The International Council for Harmonisation has announced the adoption of a harmonization topic that will address factors that must be considered in determining the utility of comparative efficacy studies in biosimilar development programs.
The new ICH Multidisciplinary Guideline was unveiled at a recent meeting in Madrid, but the starting timeframe will be determined...
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.
Generic dapagliflozin rivals to AstraZeneca’s Forxiga are now free to hit the UK market after the country’s Supreme Court lifted the final barrier preventing launch, allowing off-patent firms access to a market worth hundreds of millions of pounds annually.
Germany’s Federal Patent Court has invalidated Bayer’s key patent covering once-daily use of Xarelto (rivaroxaban), paving the way for Sandoz to launch a generic version. Bayer is considering an appeal.
The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. But, as Medicines UK’s CEO Mark Samuels tells Generics Bulletin, companies are still facing multiple hurdles in the market.
