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Regulation

Set Alert for Regulation

EMA Recommends Dozens Of Suspensions Over Flawed Synchron Studies

The EMA’s CHMP has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Regulation Europe

AAM Calls For FTC Scrutiny Of Pharmacy Benefit Manager Practices

Pharmacy benefit managers often fail to encourage the use of generic and biosimilar medications and in fact undermine patient access to these more affordable drugs, the Association for Accessible Medicines has told the US Federal Trade Commission.

Generic Drugs Biosimilars

Gemme Welcomes Advent Of French Biosimilar Substitution

French off-patent industry association Gemme has welcomed the entry into force of biosimilar substitution – but has protested against recent and ongoing price cuts for small-molecule generics in the context of unprecedented cost pressures.

Biosimilars France

Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research

ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.

Generic Drugs Combination Products

Stada And Calliditas Celebrate European Nod For Budesonide Hybrid

The EMA’s CHMP has issued a positive opinion for the Kinpeygo budesonide 4mg modified-release hard capsules hybrid medicine developed by Calliditas that will be marketed in Europe by Stada. Meanwhile, four generics from Accord, Fresenius Kabi, Gedeon Richter and Sun have also been endorsed by the committee.

Europe Regulation

Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

Biosimilars Regulation

UK Lucentis Biosimilar Nod Offers Teva Potential First-Mover Advantage

Teva is gearing up to introduce the Ongavia ranibizumab biosimilar in the UK, following an approval by the local regulator ahead of its European counterpart. The development means the Israeli firm and partners Bioeq and Formycon could secure a global first launch of a rival to Lucentis, ahead of expected imminent launches by Samsung Bioepis of its Byooviz version in the US and Europe.

Biosimilars Approvals

Generic Drug Sponsors Would Get More Info On Brand Inactive Ingredients Under User Fee Bill

PhRMA expresses concerns the provision would reveal trade secrets, but since the draft bill already has support from the Republican committee leadership, the brand industry may find it a challenge to get the language removed.

Generic Drugs User Fees

FDA Suggests ‘Institutional Resistance’ To Levothyroxine Generics Is Misplaced

Following the publication of a real-world case-study of levothyroxine use that included switching between different versions of the product, the FDA has suggested that “institutional resistance” to generics – including from American Thyroid Association guidance that warns against switching – “may not be supported by real-world evidence.”

Generic Drugs Regulation
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