Regulation
Japanese generics giant Sawai appears to be turning a corner, but the impact of National Health Insurance pricing revisions continues to hold the firm – and the rest of the country’s generics industry – back.
Following on from its recently announced US licensing deal with Amneal over its Xolair biosimilar, Kashiv has finished patient recruitment for a trial for the omalizumab candidate, paving the way for submissions.
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Polpharma has struck a deal with MSN Laboratories that will see the Polish generics player distribute the Indian firm’s hospital portfolio in Poland.
Following the FDA’s approval of A 150mg version of Accord’ Herceptin biosimilar, the US agency has now greenlit a higher 400mg strength version of the rival.
Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”
Generics Bulletin reviews the latest regulatory events across the world.
During Hikma’s first-half results call, the company delved into details of its strategic goals for biosimilars, small-molecule generics, injectables, GLP-1s and more.
With a clear focus on complex products, Lupin sets out its launch plans for the year ahead, while battling ongoing litigation over some of its generics.
Sandoz has delivered the first denosumab biosimilar launch in Canada, introducing its Jubbonti and Wyost rivals to Amgen’s Prolia and Xgeva.
A better balance needs to be struck in allocating resources between Europe’s centralized and decentralized procedures for generic approvals, Medicines for Europe has urged, pointing to current limitations on member states acting as reference member states for decentralized procedures.
Generics Bulletin reviews the latest regulatory events across the world.
The agency used a 10-year average with updated figures to calculate the FY 2025 PDUFA application fee and limit the impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket.
The US FDA is all ears. Stakeholders in the biosimilar industry have a chance to give their two cents about what would work best for development guidance.
Brand-backed association the Alliance for Safe Biologic Medicines has expressed caution over FDA findings that bolster the case for biosimilar switching and suggest a reduction in the need for switching studies to support interchangeability.
Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.
Generics Bulletin recaps the most recent regulatory news and updates from across the world.
The IGBA has renewed calls to streamline biosimilar development by reducing comparative clinical studies and using the same comparator product across international jurisdictions, citing the findings of a recent publication by the International Pharmaceutical Regulators Programme’s Biosimilars Working Group.