Generics Bulletin

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A well-respected and trusted industry source for the last 15 years, Generics Bulletin from Pharma Intelligence provides in-depth news and analysis on issues that matter most to businesses across the generics, biosimilars and value-added medicines industries. From business strategies, mergers and acquisitions, to manufacturing compliance, pricing and reimbursement, legislative moves, patent litigation and product launches, Generics Bulletin has you covered. Providing accurate and reliable news reports, combined with our experts’ insight and opinions, and revealing the latest strategies and the business performance of the world’s leading generics and biosimilar companies. Source

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Scope International, Trade/B2B
Language English
Country United Kingdom
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Hikma Hits Back Over Amarin’s ‘Strawman’ Induced Infringement Claims

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By Dave Wallace
| Generics Bulletin
Rebuts Originator’s ‘Safe Harbor’ Attack Ahead Of Oral Arguments As Amarin and Hikma continue to file briefs with the Supreme Court ahead of oral arguments at the end of this month in their skinny-label induced-infringement litigation over carve-outs for generic Vascepa (icosapent ethyl), the latest development sees Hikma attacking Amarin’s 'safe harbor' claims.
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Mabwell Finds A Denosumab Biosimilar Partner In Malaysia

| Generics Bulletin
Building On A Vietnamese Partnership In March Mabwell has signed a Malaysian licensing deal for its denosumab biosimilars Mailishu and Maiweijian, further expanding its footprint in Southeast Asia. (Shutterstock) Key Takeaways Mabwell shook hands with an undisclosed Malaysian partner for its two denosumab biosimilars Mailishu and Maiweijian. Mabwell has announced a licensing and commercialization agreement with a Malaysian partner for its two denosumab biosimilars.
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Apotex Snatches First FDA Generic Approval For Sandoz’s Multivitamin Injection

| Generics Bulletin
As Well As 180-Day CGT Exclusivity For Bulk Package ANDA Apotex said the approval of the generic vitamin combination injectable reflects the strong collaboration model it has with its partners Orbicular and Gland Pharma. (Shutterstock) Key Takeaways Apotex's two abbreviated new drug applications for Sandoz and Baxter's Infuvite adult multivitamin injection have been approved by the US FDA, covering both a single-dose and a pharmacy bulk package formulation.
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France’s Gemme Becomes ALMA

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By Dave Wallace
| Generics Bulletin
French Industry Association Is Latest European Body To Rebrand Becoming the latest industry association to adopt a new identity, French generics and biosimilars group Gemme has become ALMA: the alliance des médicaments abordables, or alliance for affordable medicines. ALMA is the new name for the French generics and biosimilars association (Shutterstock) Key Takeaways French off-patent industry association Gemme has adopted a new identity of ALMA.
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Mankind And Amneal Launch US Lumigan Generics Despite Valid Patent

| Generics Bulletin
Lumigan’s Last Orange Book Patent Expires In June 2027 AbbVie/Allergan’s Lumigan is now competing with two generic rivals in the US, even though the drug substance patent is still in force. (Shutterstock) Key Takeaways Mankind Pharma and Amneal have commercialized their respective bimatoprost ophthalmic solutions 0.01%, which are generic versions of AbbVie/Allergan’s Lumigan.
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‘Scale Matters And Portfolio Matters’ – Biocon’s Erick On The US Biosimilars Market

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By Dave Wallace
| Generics Bulletin
CCO For Advanced Markets Also Foresees Wave Of Consolidation Matt Erick, chief commercial officer for advanced markets at Biocon Biologics, told Generics Bulletin why he foresees consolidation on the way in the US biosimilars sector – but also why no single company can try and tackle the whole market on its own.
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Celltrion Sees Growth Opportunities As Lingering Uncertainty Over US Tariffs Is Resolved

| Generics Bulletin
Including Zymfentra, Which Is Sold As A New Drug And Not Biosimilar As the US pharma tariff drama reached its culmination, Celltrion aims to lock down its domestic manufacturing capabilities as a future-proof strategy. Meanwhile, the Korean firm expands biosimilar prescription bases in the US and Europe. (Shutterstock) Key Takeaways Celltrion said the latest announcement on US pharma tariffs has resolved any lingering uncertainties on the potential business impact.
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Outlook Goes After FDA With Formal Dispute Resolution Request

| Generics Bulletin
A Meeting With The Deciding Official Will Be Held This Month Outlook will be meeting again with the FDA to discuss the approval of its ophthalmic formulation of bevacizumab. However, this time, Outlook will go through a different procedural pathway. (Shutterstock) Key Takeaways Following its recent meeting with the FDA, Outlook has submitted a formal dispute resolution request regarding the ophthalmic bevacizumab ONS-5010/Lytenava.
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‘The Number One Priority Is Sustainable Access’ – AAM Chair Hoffman On Stabilizing The US Industry

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By Dave Wallace
| Generics Bulletin
Lupin US CCO Discusses 2026 Goals For Industry Association Fresh from taking over the role of AAM chair, Lupin’s Bob Hoffman talks to Generics Bulletin about how the “squeezed” US off-patent industry is having to work hard just to remain sustainable – and the messages that US policymakers need to hear. Lupin’s Bob Hoffman is the new AAM chair (AAM) Key Takeaways The AAM’s new chair Bob Hoffman speaks to Generics Bulletin for an exclusive interview on the US association’s priorities this year.
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‘Eggs Solve All Of Those Problems’ – How Neion Bio Is Seeking To Shake Up Biosimilar Manufacturing

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By Dave Wallace
| Generics Bulletin
Key Takeaways Neion Bio’s CEO Demetrios Kellari, chief technology officer Sam Levin and president of commercial operations Ming Li speak to Generics Bulletin about the firm’s egg-based biologic manufacturing platform. Citing recent breakthroughs in genetic engineering and stem cell biology that have made the technology viable, the founders explain how Neion Bio’s Raptor platform can cut costs and increase efficiencies.
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Generics Bulletin Journalists

Charles, Andrea
Coleman, Karen
Malone, Eleanor
Rudge, Dean
Wallace, David

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