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Interviews


Regulation


US FDA Forced To Rip Up, Start Biosimilar First Interchangeable Exclusivity Guidance Again

 

New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.

Year In Review: Most Impactful Regulatory Developments In 2024

 

We review the most notable regulatory developments of the past year, with experts outlining for Generics Bulletin the regulatory to-do list for 2025.

ANDA Yo-Yo: FDA Receives Second-Lowest Submission Count In October After September Bolus

 

The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.

Henlius Files Chinese Application For Perjeta Biosimilar

 
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A few months after a positive Phase III trial readout, Henlius has filed an application for its Organon-partnered Perjeta biosimilar in its domestic Chinese market.

Regulatory Recap: Medicines For Europe Reiterates Support For ‘Bullet-Proof’ SPC Process

 

Generics Bulletin reviews the latest developments in the regulatory arena across the globe.

US FDA Generic Drug Approvals, Other Actions Declined As Approval Times Climbed In FY 2024

 

An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.

US PTO Pulls Double-Patenting Proposals

 
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The US PTO is facing criticism after withdrawing a proposed rule that sought to address double-patenting with changes to terminal disclaimers.

Concerns Over PREVAIL Act Persist, Even With Amendment To Shield Off-Patent Drugs

 

Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs.

Value-Added Medicines


Rosemont And Hyloris Agree US Tie-Up On Valacyclovir

 
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Rosemont Pharmaceuticals will commercialize Hyloris’ proprietary valacyclovir oral suspension in the US under a new partnership that has been agreed between the two firms.

‘We’re 40 Years Behind Them And The Gap Is Growing’ – Burt Calls For European Urgency On Value Added Medicines

 
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Europe risks “missing out on a massive opportunity” if it does not improve its efforts to recognize and take advantage of the benefits of value added medicines, according to Medicines for Europe sector chair and Pharmanovia CEO James Burt.

Teva Welcomes Potential For Olanzapine ‘Running Start’ Amid Positive Clinical Data

 
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Buoyed by the success of its long-acting risperidone injectable, Teva is continuing to feel upbeat about the potential for its olanzapine LAI candidate, ahead of a full study safety readout anticipated in the first half of 2025.

Hyloris Finds A Partner In China For Maxigesic IV Amid Business Disruptions

 
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Hyloris recognized that the suspension of its shares as part of a broader business fallout has “created uncertainty and temporarily impacted management and organizational focus,” as it got another commercial deal over the line for its Maxigesic IV (paracetamol/ibuprofen) solution for infusion.

Legal & IP


Teva Ordered Again To Delist Inhaler Patents From The Orange Book. But Is This The End?

 

The fight between Teva and Amneal over the ProAir HFA inhaler has reached another milestone, with the appellate court affirming the previous ruling to delist five patents from the FDA’s Orange Book. However, Teva might not be backing down.

Five Big Legal Stories From 2024

 
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Generics Bulletin looks back at a selection of the most significant legal stories from 2024, including a surprising outcome in biosimilars, a major small-molecule generic opportunity, and a flurry of activity over GLP-1s.

Sun Gets Two-Year Jump On Zubsolv IP With Patent-Litigation Deal

 
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Only weeks before arguments were due to be heard in Sun Pharma’s appeal against an unfavorable lower court ruling over patents shielding Orexo’s Zubsolv, the two parties have shaken hands on a settlement agreement.

Fresenius Kabi Faces Decade Wait On US Cinvanti Generic

 
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Fresenius Kabi was unable to persuade a US court that its proposed generic version of Heron Therapeutics’ Cinvanti (aprepitant) injectable emulsion for chemotherapy-induced nausea and vomiting would not infringe a pair of patents stretching into the next decade.