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Bio-Thera Ventures Outside China With European Bevacizumab Filing

China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.

Biosimilars Strategy

Coronavirus Spotlight


Coronavirus Spotlight

EU Reforms Must Heed Pandemic Lessons

Reforms set out by the European Commission to better prepare the EU for future health crises must heed key lessons learned from experiences of the COVID-19 pandemic, such as the benefits of digitalization, Medicines for Europe has urged.

Policy & Regulation Europe

Accord Takes A Trio Of Awards

Accord Healthcare took home a trio of prizes at the Global Generics & Biosimilars Awards 2020, with other winners including Alvogen, Aurobindo, Dr Reddy’s, Eurofarma, Insud Pharma, Macleods, Pinsent Masons, Samsung Bioepis, Sandoz, Stada and Zentiva.

Generic Drugs Biosimilars Value-Added Medicines

Podcast: The UK's New Biosimilars Licensing Pathway

In this podcast discussion, Generics Bulletin editor David Wallace talks to Duncan Emerton, director of Custom Intelligence and Analytics for Informa Pharma Intelligence, about the UK's new licensing procedure for biosimilars.

Biosimilars Regulation United Kingdom
 

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Viatris Kickstarts Business With Tentative Approval For Pediatric Dolutegravir

The merger between Mylan and Pfizer’s Upjohn unit finally concluded on 16 November 2020, giving Viatris the go ahead for business. The newly-established company has announced receiving tentative approval for its 10mg pediatric dolutegravir tablets from the FDA under the PEPFAR program. 

Approvals Strategy

Bio-Thera Ventures Outside China With European Bevacizumab Filing

China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.

Biosimilars Strategy

Lannett Plans Seven Launches In Fiscal Year 2021

Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020. 

Biosimilars Generic Drugs

Alvotech Targets Chinese Biosimilars With Yangtze River Deal

Alvotech has struck a major deal with Yangtze River Pharmaceutical that will allow eight of the biosimilars developer’s products to be commercialized in China.

Deals China

EBITDA Margin Of 33% Not Sustainable, Krka Underlines

Krka’s bottom line continues to be stronger than usual, driven by a hike in sales and leaner cost base. Looking to 2021, however, management brought investors back down to earth.

Sales & Earnings Strategy

US Body Pits Authorized Generics Against Competitors

Pfizer’s Greenstone and Sanofi’s Winthrop have together founded a US industry body to represent authorized generics, drawing a distinction between these products and traditional generics.

Generic Drugs United States
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Policy & Regulation Explore this Topic

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EU Pharma Strategy Will Remove Barriers And Bolster Competition

The European Commission’s newly-published Pharmaceutical Strategy features a range of proposals related to generics and biosimilars, including “targeted policies” to improve competition, remove barriers and increase uptake.

Policy Europe

Trump Most-Favored-Nation Pricing Rule Criticized By The AAM

Mooted some time ago, the Medicare Part D Drug Rebate Rule and the Medicare Part B Most-Favored-Nation Model have now been finalized by US President Donald Trump. But US off-patent body the Association for Accessible Medicines feels “further action is necessary.”

Pricing Debate Regulation

Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity

The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.

Biosimilars FDA

Alvotech Files Higher-Strength Adalimumab In US And EU

Alvotech has announced the filing of its AVT02 higher-strength adalimumab version of Humira 100mg/ml with both the FDA and the EMA, as well as disclosing expected decision dates. Teva will market the biosimilar in the US and Stada in Europe.

Biosimilars Strategy

Samsung Bioepis Clears Up Second EU Bevacizumab Application

Samsung Bioepis last week received a second positive opinion recommending granting a pan-European marketing authorization for a biosimilar bevacizumab product. The Korean firm spoke to Generics Bulletin detailing the rationale.

Biosimilars Regulation

Mystery Surrounds Second Samsung Bioepis Avastin Biosimilar

Samsung Bioepis is lining up two biosimilar bevacizumab products in the EU, after the EMA’s CHMP recommended the company’s Onbevzi product months after approval for Aybintio.

Biosimilars Regulation
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Generic Drugs Explore this Topic

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EU Pharma Strategy Will Remove Barriers And Bolster Competition

The European Commission’s newly-published Pharmaceutical Strategy features a range of proposals related to generics and biosimilars, including “targeted policies” to improve competition, remove barriers and increase uptake.

Policy Europe

Pfizer Faces 15-Year Wait On US Adrenalin Generic

Pfizer’s efforts to circumvent two US patents shielding Par’s Adrenalin (epinephrine) have again ended in failure, following a ruling by the US Court of Appeals for the Federal Circuit.

Intellectual Property Generic Drugs

Lannett Plans Seven Launches In Fiscal Year 2021

Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020. 

Biosimilars Generic Drugs
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Biosimilars Explore this Topic

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Bio-Thera Ventures Outside China With European Bevacizumab Filing

China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.

Biosimilars Strategy

EU Pharma Strategy Will Remove Barriers And Bolster Competition

The European Commission’s newly-published Pharmaceutical Strategy features a range of proposals related to generics and biosimilars, including “targeted policies” to improve competition, remove barriers and increase uptake.

Policy Europe

Towa Plans 10 Launches In December 2020

After a strong first quarter, Japan’s Towa Pharmaceuticals saw stability in its domestic revenues but a drop in revenues from its overseas business in its financial second quarter. After launching a series of molecules in June 2020, the company has lined up 10 launches for December 2020 as well. 

Biosimilars Coronavirus COVID-19
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Value-Added Medicines Explore this Topic

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Industry Leaders Set Out Priorities Ahead Of Awards

Outstanding leaders in the off-patent industry have shared their thoughts on leadership priorities in an exclusive roundtable discussion being shown later today, ahead of the Global Generics & Biosimilars Awards 2020 which will be broadcast tomorrow, 3 November.

Leadership Generic Drugs

Teva Strikes Digital Deal With Amazon And Onica

To boost the technology used in its digihaler family of inhalers, Teva has partnered with Amazon Web Services and Onica, a Rackspace Technology company. With this collaboration, Teva aims to protect patients’ information and ensure data security.

Drug Delivery Digital Health

Catalent Launches Technology For Softgel Innovation

Catalent has announced the launch of a new technology, OptiGel DR, for the formulation and manufacture of delayed/enteric release softgels, offering advantages such as potentially enhancing bioavailability and reducing gastric reflux effects.

Manufacturing BioPharmaceutical
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