Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex task of regulating AI to...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Gene therapy is part of a new wave of medicine that approaches disease treatment by addressing the root causes rather than focusing on treating or reducing symptoms. Currently, gene therapies are being developed for treatment...more
Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU: On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more
LATEST KEY DEVELOPMENTS Competition & State Aid • European Commission pursues Fit for Future Platform to simplify EU law, including in the area of State aid, particularly in response to the pandemic • EU approves new...more
LATEST KEY DEVELOPMENTS - Competition & State Aid • EU approves new and amended Member State measures to support the economy • Executive Vice-President and Competition Commissioner Vestager speech on the future of State...more
Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an...more
Last week, the EMA authorized Insulin aspart Sanofi’s biosimilar product. The EMA notes on its website that Insulin aspart Sanofi is “highly similar to another biological medicine [NovoRapid] that is already authorized in the...more
Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows...more
Liability exposure and shields for vaccine developers - As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more
Last week, Mylan announced on its quarterly earnings call that the U.S. FDA has accepted the company’s aBLA for a biosimilar of AVASTIN (bevacizumab), which is now under review with a user fee goal date of December 27, 2020. ...more
Multiple sources are reporting that Celltrion is planning to roll out REMSIMA SC, its subcutaneous infliximab biosimilar of Johnson & Johnson’s autoimmune disease treatment REMICADE, in Europe in the first quarter of 2020,...more
2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more
The EMA will be launching Phase 3 of its business continuity plan on October 1, 2018 at the latest, however, the detail of the plan will now be impacted by the EMA announced this week that it has realized that it will lose...more
Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines. In addition to yesterday’s news about the U.S. FDA’s approval of...more
On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more