Generics Bulletin is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Set Alert for Regulation

Aspen Will Pay UK's NHS £8m In Landmark Deal Following Competition Probe

Aspen has agreed to pay the National Health Service £8m following an investigation by the Competition and Markets Authority.

Compliance Legal Issues

Dr Reddy's Is Knocked Back On US NuvaRing And Copaxone Rivals

Dr Reddy’s has received a further CRL from the US Food and Drug Administration over its application for a generic rival to Merck Sharp & Dohme’s NuvaRing contraceptive, along with a CRL for its version of Teva’s Copaxone.

Regulation United States

Pfenex And Alvogen May Face Delay In Teriparatide Equivalence Rating

Pfenex remains hopeful of receiving US approval for its teriparatide hybrid rival to Eli Lilly’s Forteo in October this year. But commercial partner Alvogen may have to wait for a therapeutic equivalence rating to the osteoporosis original.

Value-Added Medicines FDA

End Of Road For ‘Too Complex’ EU Pilot Program On Splitting Marketing Licenses

EU regulators have pulled the plug on a pilot program on splitting mutual recognition and decentralized procedure licences. Instead of promoting harmonization of marketing authorizations across the EU and helping companies with their marketing strategies, it has led to more problems.

Europe Generic Drugs

Pooled Data Among AAM’s Concerns On FDA’s Therapeutic Protein Biosimilars Guidance

Three key areas for improvement in in the FDA’s draft guidance on therapeutic protein biosimilars have been highlighted by industry association AAM. Pharmaceutical giants such as Pfizer, Novartis and Celltrion have also expressed concerns highlight shortcomings and sought clarification.

Biosimilars Regulation

International Regulators Dismiss Scares On Biosimilar Safety

Biosimilars have been shown to be safe and effective, and healthcare professionals should discount any scaremongering by big pharma to the contrary, the world’s leading regulatory agencies have stated.

Biosimilars Safety
See All