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Generics Bulletin Editor’s Picks For Q3 2022

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Strategy Leadership

Interviews

Interviews

What Aspects Will Give Humira Biosimilars The Edge In 2023?

With multiple Humira biosimilars slated for launch in the US next year, some simultaneously, a Vizient survey provides some insights into what could be the most important differentiating aspects. Generics Bulletin speaks to Steven Lucio, Vizient senior principal of pharmacy solutions, about the findings.

Biosimilars Market Intelligence

GGB Awards Extend Entry Deadline To 26 August

Entrants now have an additional week to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

Generic Drugs Biosimilars Value-Added Medicines
 

Commercial Explore this Topic

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IGBA And WHO Highlight Korean Training Hub

Following the announcement in February that South Korea had been chosen by the WHO as the location for a global biomanufacturing training hub, a video shared by the IGBA has shed more light on what can be expected from the initiative.

South Korea Manufacturing

Generics Bulletin Editor’s Picks For Q3 2022

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Strategy Leadership

EU Drug Supply In Jeopardy Without Energy Support, Warns Medicines For Europe

Medicines for Europe calls for the pharmaceutical industry to be excluded from energy restriction policies for winter 2022 in an open letter to EU governance bodies. Inflation and energy costs threaten European drug makers with closures and rationing, says the industry body.

Europe Regulation

Sandoz: Big Cap Biosimilar Rivals Lack Clarity On Commitment

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Biosimilars Strategy

Olon Expands On Multiple Fronts

Italian API and CDMO specialist Olon is expanding its high-potency capabilities at a site in India, at the same time as unveiling plans to invest a further €30m in a domestic biotech hub.

Manufacturing Ingredients

Canada’s Apotex Is Snapped Up By SK Capital

Apotex is to be acquired by SK Capital, the private investment firm has announced. The Canadian generics giant’s new owner has promised to invest in the firm to “support Apotex’s next phase of growth and continued innovation for patient affordability.”

Deals M & A
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Policy & Regulation Explore this Topic

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EU To Kick Off ‘Joint Action’ On Tackling Drug Shortages

The joint action on ensuring security of medicines supply will be supported by the EU regulators’ shortages task force, which is to track efforts to coordinate member state activities on the supply and availability of medicines.

Europe Regulation

Generics Bulletin Editor’s Picks For Q3 2022

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Strategy Leadership

EU Drug Supply In Jeopardy Without Energy Support, Warns Medicines For Europe

Medicines for Europe calls for the pharmaceutical industry to be excluded from energy restriction policies for winter 2022 in an open letter to EU governance bodies. Inflation and energy costs threaten European drug makers with closures and rationing, says the industry body.

Europe Regulation

Scrap Citizen Petition Proposal For 505(b)(2), Off-Patent Industry Urges FDA

Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.

FDA Drug Approval Standards

Sandoz: Big Cap Biosimilar Rivals Lack Clarity On Commitment

Sandoz has had its say on its biosimilar rivals with largely branded portfolios, as well as the recent EMA statement supporting biosimilar interchangeability.

Biosimilars Strategy

GDUFA Research Impacting Generic Development, ANDA Approvals

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

Generic Drugs Research & Development
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

Generics Bulletin Editor’s Picks For Q3 2022

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Strategy Leadership

EU Drug Supply In Jeopardy Without Energy Support, Warns Medicines For Europe

Medicines for Europe calls for the pharmaceutical industry to be excluded from energy restriction policies for winter 2022 in an open letter to EU governance bodies. Inflation and energy costs threaten European drug makers with closures and rationing, says the industry body.

Europe Regulation

‘Imminent’ Gilenya ANDA Launches Halted By US Supreme Court

In a dramatic twist, Gilenya ANDA sponsors are now unable to launch their generic products in the US after the US Supreme Court intervened in favor of originator Novartis, superseding the US Federal Circuit.

Generic Drugs Legal Issues
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Biosimilars Explore this Topic

Set Alert for Biosimilars

Generics Bulletin Editor’s Picks For Q3 2022

Looking back over the third quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from July to September that include changes in ownership on the horizon for major industry players, executive reshuffles at the top of leading companies and regulators, Generics Bulletin’s annual Top 50 and the announcement of our annual awards shortlist.

Strategy Leadership

Scrap Citizen Petition Proposal For 505(b)(2), Off-Patent Industry Urges FDA

Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.

FDA Drug Approval Standards

What’s Next? Five Things To Look Out For In October

A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

Generic Drugs Biosimilars
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

What’s Next? Five Things To Look Out For In October

A busy October will include planned biosimilar launches and key appointments for the off-patent sector.

Generic Drugs Biosimilars

Glenmark’s Ryaltris Set To Hit Canadian Market

Health Canada approves Ryaltris for allergic rhinitis, opening up yet another major market for Glenmark’s branded specialty medicine. Bausch Health will sell the drug in Canada.

Canada Approvals

Stada’s Rare Kidney Disease Drug Is EU First

Stada advances its Specialty ambitions by launching the EU’s first authorized treatment for the rare kidney disease immunoglobulin A nephropathy in the form of its modified-release budesonide capsules.

Europe Rare Diseases
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