Regulation
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
Generics Bulletin reviews several critical US bills and the off-patent industry’s response, along with budget calculations and new proposals.
Iconovo’s efforts in bringing its Breo Ellipta rival to the market continue, with positive news received from the FDA on the substitutability of the firm’s ICOpre proprietary inhaler. The firm is now seeking a partner to take the product to the next stage.
The US FDA has issued a Form 483 to Granules India, with six observations, spanning document and vent mismanagement to bird droppings and rust.
Generics Bulletin recaps the most recent regulatory news from across the world.
At the recent Morgan Stanley Healthcare Conference in New York, Sandoz leaders set out their views on the significance of – and the FDA’s initial implementation of – the US biosimilar interchangeability designation.
Generics Bulletin’s editorial team discusses recent conferences held by Medicines for Europe and the AAM, while looking ahead to the key off-patent industry events that are on the calendar over the next few months and beyond.
Teva requested the change to the draft guidance, arguing that otherwise the meetings would be “completely one-sided conversations.”
The latest batch of product-specific guidances for generic development has been published by the US Food and Drug Administration, covering products that include COVID-19 treatment Paxlovid, ear drops and various metered-dose inhalers.
Generics Bulletin reviews the latest regulatory events across the world.
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.
Johnson & Johnson’s actions to promote generic competition and lower the price for its crucial tuberculosis treatment, Sirturo (bedaquiline), have satisfied an investigation launched by South Africa’s Competition Commission.