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Amgen Delivers On Launch Of First US Humira Rival – At A 55% Discount

Amgen has confirmed its long-awaited launch of Amjevita, the first US biosimilar rival to Humira, kicking off a year of competition that will also see a second wave of adalimumab products launch in six months’ time. The company has announced that it will offer the product at a 55% discount to the originator.

Biosimilars Launches

Interviews

Interviews

Dr Reddy’s CEO Sees Strength Through Diversity

With Dr Reddy’s organization now spanning a range of innovative interests and CDMO activities as well as the firm’s traditional small-molecule generics and burgeoning biosimilars businesses, CEO Erez Israeli talked to Generics Bulletin about how these various areas were complementary thanks to the Indian giant’s ‘two-horizon’ approach.

Strategy Generic Drugs

Humira In 2023: The $17bn Biosimilar Opportunity

The advent of US biosimilar competition to Humira in 2023 represents the largest ever loss-of-exclusivity opportunity for the off-patent industry, with the first adalimumab rival expected to hit the US market at the end of this month. But with a host of other biosimilars expected to launch throughout the year, how will competition play out in the long term?

Biosimilars United States Market Intelligence
 

Commercial Explore this Topic

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HK inno.N Eyes 2025 Korea Opportunity With mAbxience Denosumab Deal

Ahead of wrapping up a Phase III clinical trial for its proposed biosimilar denosumab candidate later this year, mAbxience has out-licensed marketing rights in Korea to local player HK inno.N, with a patent expiry opportunity in 2025.

Biosimilars Deals

Dr Reddy’s Is Pushing For Progress On Multiple Fronts

Whether in the competitive world of US generics, the growing global biosimilars arena, or promising new geographical markets, Dr Reddy’s is seeking to capitalize on its strengths to remain competitive while also pushing forward with ESG goals, CEO Erez Israeli tells Generics Bulletin.

Strategy Generic Drugs

Dr Reddy’s CEO Sees Strength Through Diversity

With Dr Reddy’s organization now spanning a range of innovative interests and CDMO activities as well as the firm’s traditional small-molecule generics and burgeoning biosimilars businesses, CEO Erez Israeli talked to Generics Bulletin about how these various areas were complementary thanks to the Indian giant’s ‘two-horizon’ approach.

Strategy Generic Drugs

Teva-MedinCell Alliance Heats Up With Second Phase III Trial Underway

Teva’s partnership with MedinCell for long-acting injectable products, first penned a decade ago, is beginning to gather steam, as another candidate entered the clinic ahead of a potential first approval in the coming months.

Value-Added Medicines Clinical Trials

Sun Forwards Specialty Strategy With $576m Concert Acquisition

Sun has struck a $576m deal to acquire Concert Pharmaceuticals, picking up lead product candidate deuruxolitinib as part of an acquisition that advances the Indian firm’s specialty pivot.

Deals M & A

Fresenius Kabi: Adalimumab Customers Want Supply Guarantee, We Can Provide That

Following Fresenius Kabi’s approval in mid-December for the eighth and latest biosimilar Humira (adalimumab) product, the company’s senior vice president for biosimilars in the US spoke to Generics Bulletin about how it can stand out from the pack and why it is confident that it can succeed.

Biosimilars Manufacturing
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Policy & Regulation Explore this Topic

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BsUFA Research Roadmap Highlights Interchangeability And Reducing Trials

The FDA has published a “Research Roadmap” setting out in detail its areas of interest for the agency’s biosimilar regulatory science pilot program under BsUFA III.

Biologics Regulation

IGBA Struggles To Find Data On Global Drug Shortages For WHO

An IGBA research report suggests international health bodies lack an accurate picture of global essential medicines shortages due to issues with monitoring and recording.

International Supply Chain

Industry Warns Of New Post-Brexit ‘Cliff Edge’ For Medicines Supply To Northern Ireland

The burden of having to produce separate product packs for Great Britain and Northern Ireland is among a number of concerns raised by industry executives at a recent hearing in the House of Lords.

United Kingdom Europe

German Generic Reform To Relax Pediatric Pricing

Germany’s Bundesministerium für Gesundheit is reworking the country’s off-patent drug legislation to allow for more flexible pricing.

Germany Generic Drugs

Biosimilars Forum Urges Equal Access For US Humira Rivals

With the US on the cusp of biosimilar competition to Humira, Julie Reed – executive director of the country’s Biosimilars Forum – has urged PBMs to bolster access by making all adalimumab biosimilars available as they launch throughout 2023.

Biosimilars United States

A Bad Fit: Dan Leonard’s Leadership Style Did Not Translate At AAM

Former employees at the Association for Accessible Medicines detail problems that emerged during Leonard’s tenure, but also say the board of directors must improve its management of the trade organization.

Leadership United States
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Generic Drugs Explore this Topic

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PBMs’ ‘Perverse Incentives’ Still Limiting Generics Access, AAM Report Reiterates

Generic medicines continue to be intentionally left off formulary tiers in favor of more expensive brand medications, according to a new report from the US Association for Accessible Medicines.

Generic Drugs United States

Sandoz Gets EU Nod For Higher-Strength Adalimumab

Sandoz has received a positive opinion from the EMA’s CHMP recommending that its high-concentration 100mg/ml adalimumab biosimilar be granted a pan-European marketing authorization. Three generics were also endorsed at the CHMP’s January meeting, including a rival to Forxiga.

Biosimilars Approvals

Dr Reddy’s Is Pushing For Progress On Multiple Fronts

Whether in the competitive world of US generics, the growing global biosimilars arena, or promising new geographical markets, Dr Reddy’s is seeking to capitalize on its strengths to remain competitive while also pushing forward with ESG goals, CEO Erez Israeli tells Generics Bulletin.

Strategy Generic Drugs
See All

Biosimilars Explore this Topic

Set Alert for Biosimilars

HK inno.N Eyes 2025 Korea Opportunity With mAbxience Denosumab Deal

Ahead of wrapping up a Phase III clinical trial for its proposed biosimilar denosumab candidate later this year, mAbxience has out-licensed marketing rights in Korea to local player HK inno.N, with a patent expiry opportunity in 2025.

Biosimilars Deals

Amgen Delivers On Launch Of First US Humira Rival – At A 55% Discount

Amgen has confirmed its long-awaited launch of Amjevita, the first US biosimilar rival to Humira, kicking off a year of competition that will also see a second wave of adalimumab products launch in six months’ time. The company has announced that it will offer the product at a 55% discount to the originator.

Biosimilars Launches

PBMs’ ‘Perverse Incentives’ Still Limiting Generics Access, AAM Report Reiterates

Generic medicines continue to be intentionally left off formulary tiers in favor of more expensive brand medications, according to a new report from the US Association for Accessible Medicines.

Generic Drugs United States
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Value-Added Medicines Explore this Topic

Set Alert for Value-Added Medicines

Teva-MedinCell Alliance Heats Up With Second Phase III Trial Underway

Teva’s partnership with MedinCell for long-acting injectable products, first penned a decade ago, is beginning to gather steam, as another candidate entered the clinic ahead of a potential first approval in the coming months.

Value-Added Medicines Clinical Trials

Viatris’ Once-Monthly Copaxone Filing Imminent, Botox ‘On Track’

Fresh from offloading almost all its interests in biosimilars to Biocon, Viatris continues to develop several follow-on products, which it hopes will add $1bn to the company’s top line by the end of the decade.

Value-Added Medicines United States

Standalone Sandoz And Biocon’s Biosimilars: 2022’s Biggest Deals

The acquisition and consolidation mania that gripped industry in the middle half of the last decade may seem like a distant dream but players continued to spend cash where it could be justified in 2022, while raising much-needed capital to fund their endeavors.

M & A Deals
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