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Central Role For Industry Beckons As Europe Rebuilds After COVID

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

Policy Regulation

Coronavirus Spotlight

Coronavirus Spotlight

Bill & Melinda Gates Foundation Commits $120m For Molnupiravir In Lower-Income Countries

The Bill & Melinda Gates Foundation has extended a financial commitment of up to $120m to secure a dedicated, low-cost supply of generic molnupiravir to lower-income countries. The Gates Foundation is looking to “significantly reduce the time it takes for a new drug to reach low-income countries after it becomes available in high-income markets.”

International Coronavirus COVID-19

Interviews

Interviews

Phlow Seeks To Build On Fresenius Kabi Collaboration

US-based Phlow and Fresenius Kabi have announced an alliance to supply essential medicines, including injectables, for public health emergencies and to Children’s Hospital Coalition, a project by Phlow. In an exclusive interview with Generics Bulletin, Phlow chief business officer Dan Hackman talks about the partnership, addressing US supply chain disruptions, domestic manufacturing and more.

United States Deals




OUTLOOK 2021



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




VIEW 2021 RANKINGS




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 Strategy
 

Commercial Explore this Topic

Set Alert for Commercial

Roche Makes Tocilizumab Launch Prediction As Biosimilars Progress

Roche gave small insight into its expectations around biosimilar competition for its Actemra/RoActemra (tocilizumab) treatment for inflammatory diseases. Extraordinary demand for the biologic led sales to skyrocket by 143% in the third quarter and caused supply constraints for the originator.

Biosimilars Market Access

Bill & Melinda Gates Foundation Commits $120m For Molnupiravir In Lower-Income Countries

The Bill & Melinda Gates Foundation has extended a financial commitment of up to $120m to secure a dedicated, low-cost supply of generic molnupiravir to lower-income countries. The Gates Foundation is looking to “significantly reduce the time it takes for a new drug to reach low-income countries after it becomes available in high-income markets.”

International Coronavirus COVID-19

180 Life Sciences’ Woody Sets Out Vision For Repurposing Anti-TNF Biologics

After 180 Life Sciences recently struck a deal with Korea’s Celltrion to support its work in repurposing off-patent biologics, CEO Jim Woody speaks to Generics Bulletin about what the collaboration means for the company and its next steps.

Deals Strategy

FDA Will Take Action On Biosimilars Delayed By Inspection Lag

With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.

Biosimilars FDA

Hyloris Prepares For UK And Ireland Maxigesic IV Launch

Value-added medicines specialist Hyloris has announced launch plans for its Maxigesic IV analgesic in the UK and Ireland after receiving approvals for the intravenous paracetamol/ibuprofen solution. The nods follow two deals aimed at bolstering the firm’s pipeline.

Approvals Deals

Sawai Cites Broader Supply Issue As It Plots Construction Of A New Facility

Japan’s Sawai was cautioned by one analyst earlier this year that it lacked sufficient excess production capacity to handle the sharp expansion in demand for its products. Now the company has announced plans to build a new solid dosage form facility.

Manufacturing Strategy
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

EMA Moves Ahead With Tailored Scientific Advice For Biosimilars

A European Medicines Agency pilot scheme offering tailored scientific advice on biosimilar development has been viewed by applicants as a “valuable opportunity” and the process will continue as part of regular operations, according to an agency report.

Biosimilars Europe

Central Role For Industry Beckons As Europe Rebuilds After COVID

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

Policy Regulation

Legal Certainty Needed On Northern Ireland, Industry Insists

A continuing lack of legal certainty continues to plague suppliers to the Northern Ireland market despite the latest proposals from the EU Commission, UK and European off-patent industry leaders Mark Samuels and Adrian van den Hoven tell Generics Bulletin.

Policy Regulation

FDA Will Take Action On Biosimilars Delayed By Inspection Lag

With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.

Biosimilars FDA

France’s Gemme Pushes Back Against Lack Of Government Action

French off-patent association Gemme has hit back after the country’s latest annual PLFSS social security legislation contained a lack of measures to boost generics and biosimilars. Three key policy proposals have been outlined by the industry body.

Policy France

Will All US Biosimilar mAbs Be Interchangeable In The Long Run?

As Boehringer Ingelheim’s Cyltezo has become the second-ever interchangeable biosimilar approved by the US FDA – as well as the first monoclonal antibody to garner the designation and offering the first published data from a switching trial to support interchangeability – the debate around the potential impact for interchangeable products in the keenly-watched adalimumab space and beyond continues to grow.

Biosimilars Regulation
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

Central Role For Industry Beckons As Europe Rebuilds After COVID

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

Policy Regulation

Bill & Melinda Gates Foundation Commits $120m For Molnupiravir In Lower-Income Countries

The Bill & Melinda Gates Foundation has extended a financial commitment of up to $120m to secure a dedicated, low-cost supply of generic molnupiravir to lower-income countries. The Gates Foundation is looking to “significantly reduce the time it takes for a new drug to reach low-income countries after it becomes available in high-income markets.”

International Coronavirus COVID-19

Phlow Seeks To Build On Fresenius Kabi Collaboration

US-based Phlow and Fresenius Kabi have announced an alliance to supply essential medicines, including injectables, for public health emergencies and to Children’s Hospital Coalition, a project by Phlow. In an exclusive interview with Generics Bulletin, Phlow chief business officer Dan Hackman talks about the partnership, addressing US supply chain disruptions, domestic manufacturing and more.

United States Deals
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

EMA Moves Ahead With Tailored Scientific Advice For Biosimilars

A European Medicines Agency pilot scheme offering tailored scientific advice on biosimilar development has been viewed by applicants as a “valuable opportunity” and the process will continue as part of regular operations, according to an agency report.

Biosimilars Europe

Roche Makes Tocilizumab Launch Prediction As Biosimilars Progress

Roche gave small insight into its expectations around biosimilar competition for its Actemra/RoActemra (tocilizumab) treatment for inflammatory diseases. Extraordinary demand for the biologic led sales to skyrocket by 143% in the third quarter and caused supply constraints for the originator.

Biosimilars Market Access

Central Role For Industry Beckons As Europe Rebuilds After COVID

Generic and biosimilar medicines must become central to European healthcare policy as the region looks to rebuild in the wake of the COVID-19 pandemic, Medicines for Europe’s new president, Rebecca Guntern of Sandoz, tells Generics Bulletin in an exclusive interview.

Policy Regulation
See All

Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

Adamis Receives FDA Approval For 505(b)(2) Naloxone

Adamis has announced receiving FDA approval for Zimhi, its high-dose naloxone hydrochloride for injection, indicated for the treatment of opioid overdose. The company has partnered with US WorldMeds to market Zimhi by the first quarter of 2022. 

United States Approvals

Hyloris Prepares For UK And Ireland Maxigesic IV Launch

Value-added medicines specialist Hyloris has announced launch plans for its Maxigesic IV analgesic in the UK and Ireland after receiving approvals for the intravenous paracetamol/ibuprofen solution. The nods follow two deals aimed at bolstering the firm’s pipeline.

Approvals Deals

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
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