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Interviews

Interviews

‘Significant Discounts’ For Biosimilars Could Disrupt US Market

With the launch of rivals to Humira looming in 2023, removing barriers to free pricing and reforming formularies will be essential to promote biosimilar competition in the US, according to Wayne Winegarden of the Pacific Research Institute.

Biosimilars Pricing Strategies

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

Set Alert for Commercial

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

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

FDA Seeks New Generics Chief As Choe Moves On

The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.

Leadership Executive Changes

Prestige Pulls Trastuzumab After EMA Knockback

Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.

Biosimilars Europe
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Policy & Regulation Explore this Topic

Set Alert for Policy and 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

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

FDA Seeks New Generics Chief As Choe Moves On

The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.

Leadership Executive Changes

Pharma Readies For Price Caps On Glargine, Teneligliptin, Lenalidomide In India

India’s national list of essential medicines 2022 features 34 additions, including insulin glargine, teneligliptin, lenalidomide, bedaquiline and montelukast, with price control expected to follow on these drugs.

Policy India

EMA And HMA Speak Out In Favor Of Biosimilar Interchangeability

Stakeholders in Europe have been hesitant to allow interchangeable substitution of biological products, prompting the European Medicines Agency to clarify its stance on the issue.

Biosimilars Europe

EU Gears Up For Compulsory Licensing Reform

The European Commission has laid out a number of possibilities for changing the EU framework on compulsory licensing to improve the availability of products in health emergencies. The options include extending the scope of compulsory licences beyond patents to other forms of protection such as data exclusivity.

Intellectual Property Europe
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Generic Drugs Explore this Topic

Set Alert for Generic Drugs

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

US Federal Circuit Will Not Stand In Way Of Gilenya Generics

ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.

Generic Drugs Legal Issues

US Patients Continue To Overpay For Off-Patent Drugs Despite $373bn In Savings

The US Association for Accessible Medicines’ annual report into generic and biosimilar savings has documented another year of increased cost savings thanks to off-patent drugs, but says some patients are still overpaying for their generic medicines. 

Generic Drugs Biosimilars
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Biosimilars Explore this Topic

Set Alert for Biosimilars

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

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

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
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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
See All
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