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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.
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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.
Fresenius Kabi: Adalimumab Customers Want Supply Guarantee, We Can Provide That
Biogen: Patients Must Be At Center Of UK Biosimilar Decision Making
Regulatory Reform Could Elevate Value-Added Medicines To Their ‘Rightful Place’, Says Narayan
Rani Therapeutics: ‘We’ve Tested A Dozen Molecules, All Of Them Have Worked’
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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?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Biosimilars 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.
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.
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.
Value-Added Medicines Explore this Topic
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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.
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.
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.
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