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Troubled Teligent Enters Bankruptcy Proceedings As CEO Resigns

Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.

Legal Issues Deals

Coronavirus Spotlight

Coronavirus Spotlight

Celltrion’s COVID-19 Treatment Regdanvimab Is Approved In Korea

Celltrion continues to eye further markets for its CT-P59 regdanvimab monoclonal antibody treatment for COVID-19, especially in the EU, after winning final approval from the Korean Ministry of Food and Drug Safety.

Coronavirus COVID-19 Approvals

Interviews

Interviews

Teva’s Baeder: We Need To ‘Crack The Nut’ Of Complex Generics

Industry and regulators need to collaborate to provide complex generics with the opportunity to build even further on the significant contributions already made by off-patent medicines to savings and access, Christine Baeder, senior vice president and chief operating officer of Teva’s US generics division, tells Generics Bulletin in the first part of an exclusive interview.

Strategy Generic Drugs




OUTLOOK 2021



In Vivo’s annual showcase of special features and industry league tables for pharma, medtech and generics companies




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Shortlist Revealed For GGB Awards

Finalists across all 14 categories of the Global Generics & Biosimilars Awards 2021 have been revealed ahead of the awards ceremony on 10 November, following record entries this year.

Generic Drugs Biosimilars Value-Added Medicines
 

Commercial Explore this Topic

Set Alert for Commercial

FDA Seeks Feedback On Continuous Manufacturing

A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.

Guidance Documents Manufacturing

Troubled Teligent Enters Bankruptcy Proceedings As CEO Resigns

Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.

Legal Issues Deals

Generics Bulletin Editor’s Picks For Q3 2021

Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

Generic Drugs Biosimilars

Zentiva Reveals Progress On Sitagliptin

Zentiva’s Zent2U B2B unit has reported progress on a bioequivalence study for its sitagliptin tablets, indicating that its version will be ready for day-one entry in Europe. The development comes shortly after Zent2U announced the successful completion of a sertraline study.

Generic Drugs Europe

US Bill Would Create Emergency API Stockpile

US representatives Abigail Spanberger and David McKinley have introduced bipartisan legislation to create an emergency supply of active ingredients used in vital generics and to incentivize domestic manufacturing of these ingredients. The move has garnered support from many industry leaders.

United States Coronavirus COVID-19

Xbrane Secures Patents For Low-Cost Biosimilar Production

Xbrane Biopharma has celebrated after being granted two Swedish patents covering its “high-yield” protein expression platform that the biosimilars specialist expects to act as the basis for international applications.

Intellectual Property Biosimilars
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Policy & Regulation Explore this Topic

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EU Revamps Plans To Ease Medicines Trade Between GB and NI

Proposals on medicines put forward by the European Commission are part of a package of measures to improve the implementation of the Northern Ireland Protocol by relaxing checks on goods moving across the Irish sea.

Europe United Kingdom

US Bill Would Create Emergency API Stockpile

US representatives Abigail Spanberger and David McKinley have introduced bipartisan legislation to create an emergency supply of active ingredients used in vital generics and to incentivize domestic manufacturing of these ingredients. The move has garnered support from many industry leaders.

United States Coronavirus COVID-19

Off-Patent Industry Must Become ‘Focal Point’ For Health Systems Post-COVID

Off-patent medicines must become the “focal point” of pharmaceutical policies across the world as health systems recover from the COVID-19 pandemic, Medicines for Europe and the IGBA have urged as they held their joint annual conference in Athens, Greece.

Policy Generic Drugs

Amgen Urges Balance In US Biosimilars Policy

Amgen’s recent study on biosimilars trends has outlined the importance of US policy in the success of the biosimilars marketplace, insisting on the importance of increased competition and effective reimbursement and education policies. But with interests in innovative biologics as well as biosimilars, the company has also emphasized that pro-biosimilars policies must not stifle innovation and compromise free competition.

Biosimilars Policy

US FDA Unlikely To Issue Broad Biosimilar Guidance Saying Comparative Clinical Studies Unnecessary

OTBB head Sarah Yim says FDA internal thinking is not aligned on the idea and that a lot of convincing was necessary to drop the clinical study requirement for insulin biosimilars.

Biosimilars Drug Approval Standards

FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?

Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.

Review Pathway Regulation
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Generic Drugs Explore this Topic

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Generics Bulletin Editor’s Picks For Q3 2021

Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

Generic Drugs Biosimilars

Zentiva Reveals Progress On Sitagliptin

Zentiva’s Zent2U B2B unit has reported progress on a bioequivalence study for its sitagliptin tablets, indicating that its version will be ready for day-one entry in Europe. The development comes shortly after Zent2U announced the successful completion of a sertraline study.

Generic Drugs Europe

US Bill Would Create Emergency API Stockpile

US representatives Abigail Spanberger and David McKinley have introduced bipartisan legislation to create an emergency supply of active ingredients used in vital generics and to incentivize domestic manufacturing of these ingredients. The move has garnered support from many industry leaders.

United States Coronavirus COVID-19
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

Generics Bulletin Editor’s Picks For Q3 2021

Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

Generic Drugs Biosimilars

Off-Patent Industry Must Become ‘Focal Point’ For Health Systems Post-COVID

Off-patent medicines must become the “focal point” of pharmaceutical policies across the world as health systems recover from the COVID-19 pandemic, Medicines for Europe and the IGBA have urged as they held their joint annual conference in Athens, Greece.

Policy Generic Drugs

Amgen Urges Balance In US Biosimilars Policy

Amgen’s recent study on biosimilars trends has outlined the importance of US policy in the success of the biosimilars marketplace, insisting on the importance of increased competition and effective reimbursement and education policies. But with interests in innovative biologics as well as biosimilars, the company has also emphasized that pro-biosimilars policies must not stifle innovation and compromise free competition.

Biosimilars Policy
See All

Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

Glenmark Celebrates European Ryaltris Approvals

Glenmark is celebrating the approval of its Ryaltris nasal spray in 13 European countries, with the Indian company and partner Menarini set to begin rolling out the allergic rhinitis combination product.

Value-Added Medicines Approvals

Bio-Thera And Intract Partner For Oral mAb Project

Chinese biosimilars specialist Bio-Thera Solutions has struck a licensing deal with Intract Pharma that will give it access to drug delivery technologies that will be used to develop novel oral monoclonal antibody treatments for gastrointestinal inflammatory indications.

Biosimilars Deals

Irish Body Urges Simplified Route For Value Added Medicines

Medicines for Ireland has called for a change of the “cumbersome, complex, costly and unclear regulatory processes” for value added medicines in Ireland. In conjunction with Medicines for Europe, the Irish association has published a report on the authorities to encourage innovation around existing molecules in the form of repurposing, reformulation and combination of therapies.

Value-Added Medicines Policy
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