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Featured Stories


 

Trio Face 11 Year Wait On Eliquis As US Patents Upheld

Three ANDA sponsors – HEC’s Sunshine Lake, Sigmapharm and Unichem – for generic versions of Eliquis had elected to take their Hatch-Waxman case to trial but were soundly beaten by originator’s Bristol-Myers Squibb and Pfizer. A launch in 2031 could now be their best, and only, option.

Legal Issues Intellectual Property

Coronavirus Spotlight


Coronavirus Spotlight

Procurement Must Look Beyond Price To Ensure Supply Chain Security

A globally co-ordinated approach to sourcing that rewards non-pricing criteria is imperative to bolster the security of the off-patent industry’s supply chain in the wake of the coronavirus pandemic, James Burt tells Generics Bulletin in the second part of our exclusive interview.

Pricing Strategies Manufacturing

The Global Generics & Biosimilars Awards 2020 Is Going Digital

The Global Generics & Biosimilars Awards 2020 will take place on 3 November as a digital event, with a newly-extended entry deadline date of 14 August.

Generic Drugs Biosimilars Value-Added Medicines

Generics Industry Experiences Extraordinary First Quarter Due To COVID-19 Crisis

Coronavirus-induced stockpiling and advanced prescribing of medicines has resulted in generics companies across the world registering unprecedented growth during the first quarter of 2020. However, many companies predict sales will level off again in the next quarter and beyond. And as demand fluctuates following the COVID-19 outbreak, companies have started taking precautionary measures to avoid supply-chain disruptions.  

Coronavirus COVID-19 Generic Drugs Trends
 

Commercial Explore this Topic

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New Exposure Limits For Excipients Applauded

The US FDA has launched the second phase of an effort to improve its inactive ingredients database by replacing confusing potency amounts with maximum daily exposure limits, a change sought by generic drug and excipient manufacturers.

Manufacturing Quality

Teva Still Hopes To Reach Deal On US Price-Fixing Allegations

Teva says it remains hopeful that it can resolve US price-fixing allegations “in a positive way” with the US Department of Justice, but acknowledges that the matter could go all the way to trial.

Legal Issues Pricing Strategies

Rosemont Deal Shows Value Is Out There For US Exit, Perrigo Says

Perrigo management provided colorful commentary on Perrigo’s latest endeavors to separate the company’s US generics business, following the recent sale of Perrigo’s Rosemont Pharmaceuticals subsidiary for an “attractive” multiple.

Generic Drugs M & A

FDA Expedites ANDA Postapproval Manufacturing Changes

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

User Fees Generic Drugs

Teva And Alvotech Strike US Biosimilars Pact

Teva and Alvotech have announced a major biosimilars alliance covering five products for the US market.

Deals Biosimilars

Fresenius Kabi’s EU Biosimilars ‘Lagging Behind Expectations’

Fresenius Kabi is looking to make headway into biosimilars but saw its progress limited by COVID-19 in Q2. Management gave an update on the company’s endeavors during the Q2 earnings call, including key tender victories.

Sales & Earnings Biosimilars
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Policy & Regulation Explore this Topic

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FDA Updates ‘Purple Book’ Database

The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.

Biosimilars FDA

FDA Expedites ANDA Postapproval Manufacturing Changes

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

User Fees Generic Drugs

Industry Offers Mixed Response To Latest Brexit Advice

While the off-patent industry has welcomed concrete advice from the UK government over potential disruptions to medicines supplies when the country’s transition period with the EU expires on 31 December, concerns have been raised over the ability to build up safety stocks in the context of the COVID-19 pandemic, as well as a lack of clarity over the future regulatory landscape and pandemic-related procurement initiatives.

Brexit Trade

UK Recommends Against Common Drugs For Chronic Primary Pain

Paracetamol, opioids and non-steroidal anti-inflammatory drugs are among the common medicines that “can do more harm than good” and should not be used for managing chronic primary pain, according to a draft NICE guideline.

Regulation Generic Drugs

WHO Prequalifies More Biosimilars

The World Health Organization has recently added further biosimilar versions of trastuzumab to its list of prequalified products, along with Roche’s original trastuzumab and rituximab brands, Herceptin and MabThera/Rituxan.

Biosimilars Regulation

Procurement Must Look Beyond Price To Ensure Supply Chain Security

A globally co-ordinated approach to sourcing that rewards non-pricing criteria is imperative to bolster the security of the off-patent industry’s supply chain in the wake of the coronavirus pandemic, James Burt tells Generics Bulletin in the second part of our exclusive interview.

Pricing Strategies Manufacturing
See All

Generic Drugs Explore this Topic

Set Alert for Generic Drugs

Trio Face 11 Year Wait On Eliquis As US Patents Upheld

Three ANDA sponsors – HEC’s Sunshine Lake, Sigmapharm and Unichem – for generic versions of Eliquis had elected to take their Hatch-Waxman case to trial but were soundly beaten by originator’s Bristol-Myers Squibb and Pfizer. A launch in 2031 could now be their best, and only, option.

Legal Issues Intellectual Property

Rosemont Deal Shows Value Is Out There For US Exit, Perrigo Says

Perrigo management provided colorful commentary on Perrigo’s latest endeavors to separate the company’s US generics business, following the recent sale of Perrigo’s Rosemont Pharmaceuticals subsidiary for an “attractive” multiple.

Generic Drugs M & A

FDA Expedites ANDA Postapproval Manufacturing Changes

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

User Fees Generic Drugs
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

FDA Updates ‘Purple Book’ Database

The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.

Biosimilars FDA

Cadila Pharma Launches Rituximab And Teriparatide Biosimilars In India

After launching a biosimilar to Avastin (bevacizumab) in India, Cadila Pharma has now also launched rituximab and teriparatide biosimilars in its domestic market.

India Biosimilars

Teva And Alvotech Strike US Biosimilars Pact

Teva and Alvotech have announced a major biosimilars alliance covering five products for the US market.

Deals Biosimilars
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

Basaglar Sales Level Off For Lilly

Eli Lilly has seen sales of its Basaglar insulin glargine hybrid remain static in the second quarter of 2020. However, the company reported total sales for the first half that were up by a tenth compared to the first half of 2019.

Sales & Earnings Value-Added Medicines

Procurement Must Look Beyond Price To Ensure Supply Chain Security

A globally co-ordinated approach to sourcing that rewards non-pricing criteria is imperative to bolster the security of the off-patent industry’s supply chain in the wake of the coronavirus pandemic, James Burt tells Generics Bulletin in the second part of our exclusive interview.

Pricing Strategies Manufacturing

Two Weeks Remain To Enter Global Generics & Biosimilars Awards 2020

Two weeks remain for companies to submit entries to the Global Generics & Biosimilars Awards 2020, with the entry deadline date of 14 August fast approaching ahead of the digital event on 3 November.

Generic Drugs Biosimilars
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