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Biosimilars & Generics

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EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Europe Approvals

EMA Recommends Dozens Of Suspensions Over Flawed Synchron Studies

The European Medicines Agency's human medicines committee 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

Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances

FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

Generic Drugs Legislation

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

House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval

Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.

User Fees Legislation

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

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 User Fees

Was Apokyn Safety Update A Missed Opportunity For Supernus To Hold Off Generic Refill Cartridge?

US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.

Generic Drugs Review Pathway

Inactive Ingredient Disclosure Expansion In House User Fee Bill Poised For Changes

Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.

Generic Drugs User Fees

US FDA Aims To Simplify Terminology For Remote Assessments

The use of various acronyms – including RRA, RIE and RRR – to describe remote assessments of sites and study data has been confusing and makes it sound as though people are speaking ‘like a pirate,’ Office of Study Integrity and Surveillance director Sean Kassim says.

Clinical Trials Generic Drugs

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

Trimming The Tree: What’s In The PDUFA Legislative Package – And What’s Out

The must-pass bill has many FDA policy ornaments hanging from it, but the version released by Democratic and Republican committee leadership has notable absences as well, including Cures 2.0.

User Fees Legislation
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