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Coronavirus Spotlight


Coronavirus Spotlight

WHO Launches COVID-19 Technology Access Pool

C-TAP, the voluntary initiative aimed at making vaccines, tests, treatments and other health technologies to fight COVID-19 accessible to all, has been launched by the WHO, in partnership with Costa Rica.

Coronavirus COVID-19 Vaccines

IQVIA Backs Global Generics & Biosimilars Awards 2020

IQVIA has joined the Global Generics & Biosimilars Awards 2020 as headline sponsor, while West AccelTRA will lend its backing to the awards as a category sponsor. The awards, which are free to enter and attend, will take place in October 2020 in Milan, Italy.

Generic Drugs Biosimilars Value-Added Medicines

Gedeon Richter Chief Makes Biosimilars Prophecy

Gedeon Richter has high ambitions for biosimilars, recently penning a deal to bring in a tocilizumab biosimilar that is currently under development. During its first-quarter earnings call, the Hungarian company’s CEO gave his current thinking on how payers may treat biosimilars amidst the COVID-19 pandemic.

Biosimilars Coronavirus COVID-19 Sales & Earnings
 

Commercial Explore this Topic

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AAM Urges US Senate To Back Domestic Production

While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”

Manufacturing United States

Celltrion Selected For Korean-Made Insulin Biosimilar

Korean firm Celltrion is aiming to move production of insulin pens inside Korea “for the first time” and break the stranglehold of Big Pharma insulin players in the market by launching a biosimilar product in 2025.

Biosimilars Strategy

Mylan And Lupin Prepare To Launch EU Etanercept

Mylan and Lupin have revealed when they expect to launch their etanercept biosimilar, Nepexto, in Europe after receiving formal European Commission approval.

Biosimilars Approvals

Alvogen Group Unveils Adalvo B2B Unit

The Alvogen group of companies has unveiled Adalvo as the new identity for its B2B business unit. In an exclusive interview, general manager Anil Okay talks to Generics Bulletin about the reasons behind the rebranding, what makes it unique in the B2B sphere, and the significance of 2023 for Adalvo’s strategy.

Strategy Manufacturing

Mylan And Pfizer Announce Key Date For Viatris Merger

Mylan and Pfizer’s Upjohn have revealed a key date for their merger to create Viatris, after the deal set for midway through the year was pushed back recently due to the coronavirus pandemic.

Deals Strategy

COVID-19 Demand Gives Lupin Optimism On Albuterol

Lupin hopes a surge in demand for albuterol sulphate due to increased off-label use in COVID-19 patients will help its generic version, which is likely to be launched in the first half of FY21. But the Indian firm may recall a batch of metformin after the US FDA recently asked a few companies to retract extended-release versions due to NDMA concerns.

Strategy Coronavirus COVID-19
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Policy & Regulation Explore this Topic

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FDA Re-Evaluates Orange Book Patents

With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.

Intellectual Property Regulation

CJEU Opinion Backs Lundbeck Fine Over Citalopram ‘Pay For Delay’ Deals

A CJEU advocate general has backed a European Commission fine of almost €94m imposed on Lundbeck over “pay for delay” deals struck with four generics firms over citalopram.

Legal Issues Regulation

Mylan And Pfizer Announce Key Date For Viatris Merger

Mylan and Pfizer’s Upjohn have revealed a key date for their merger to create Viatris, after the deal set for midway through the year was pushed back recently due to the coronavirus pandemic.

Deals Strategy

FDA Asks For Input On Therapeutic Equivalence

The FDA wants to know if the second letter in its product equivalence ratings system is helpful and whether changes could make the information more user-friendly.

Regulation United States

Mylan Pulls Generic Gilenya Application Over Study Concerns

Separate concerns raised by the EMA over bioequivalence studies have led Mylan and Accord to withdraw generic applications, including the former’s generic version of Gilenya for the treatment of multiple sclerosis.

Generic Drugs Regulation

Anti-Generic Tactics Attacked In Austria

Austria’s competition authority is seeking a ruling that an originator abused its dominant position through “dumping prices” to remove the incentive to switch to an oncology generic.

Regulation Austria
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Generic Drugs Explore this Topic

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AAM Urges US Senate To Back Domestic Production

While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”

Manufacturing United States

FDA Re-Evaluates Orange Book Patents

With an eye toward addressing uncertainty as to whether patents that cover drug products’ device components or risk management elements should be listed, the agency seeks input on the need for additional clarity around the types of patents that must be submitted and the impact of any change in listing practices on drug development.

Intellectual Property Regulation

Alvogen Group Unveils Adalvo B2B Unit

The Alvogen group of companies has unveiled Adalvo as the new identity for its B2B business unit. In an exclusive interview, general manager Anil Okay talks to Generics Bulletin about the reasons behind the rebranding, what makes it unique in the B2B sphere, and the significance of 2023 for Adalvo’s strategy.

Strategy Manufacturing
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Biosimilars Explore this Topic

Set Alert for Biosimilars

AAM Urges US Senate To Back Domestic Production

While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”

Manufacturing United States

Celltrion Selected For Korean-Made Insulin Biosimilar

Korean firm Celltrion is aiming to move production of insulin pens inside Korea “for the first time” and break the stranglehold of Big Pharma insulin players in the market by launching a biosimilar product in 2025.

Biosimilars Strategy

Mylan And Lupin Prepare To Launch EU Etanercept

Mylan and Lupin have revealed when they expect to launch their etanercept biosimilar, Nepexto, in Europe after receiving formal European Commission approval.

Biosimilars Approvals
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

Alvogen Group Unveils Adalvo B2B Unit

The Alvogen group of companies has unveiled Adalvo as the new identity for its B2B business unit. In an exclusive interview, general manager Anil Okay talks to Generics Bulletin about the reasons behind the rebranding, what makes it unique in the B2B sphere, and the significance of 2023 for Adalvo’s strategy.

Strategy Manufacturing

Value-Added Specialist Hyloris Launches IPO

Value-added medicines specialist Hyloris Pharmaceuticals is launching an IPO to provide the funds it needs to focus on opportunities through the US 505(b)(2) pathway.

Strategy Value-Added Medicines

Virpax And MedPharm Advance Diclofenac Spray

Virpax Pharmaceuticals and partner MedPharm say they have made progress towards filing through the US 505(b)(2) hybrid pathway a diclofenac spray for treating osteoarthritis of the knee.

Value-Added Medicines United States
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