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Aspen has agreed to pay the National Health Service £8m following an investigation by the Competition and Markets Authority.
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.
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.
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.
Three key areas for improvement in in the FDA’s draft guidance on therapeutic protein biosimilars have been highlighted by industry association AAM.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 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.
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