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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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Advanz Agrees Multi-Market Omalizumab Deal With Alvotech

Advanz and Alvotech have struck a deal that will give Advanz exclusive rights to the biosimilars developer’s Xolair (omalizumab) rival in multiple markets around the world.

Deals Biosimilars

Lannett Eyes Another $11m In Savings With R&D Sea Change, Job Cuts

Lannett unveiled another round of cost-saving initiatives alongside its financial Q2 earnings, including plans for a radical change for its R&D development.

Restructuring Sales & Earnings

Henlius Kicks Off Trial For Darzalex Biosimilar

Shanghai Henlius Biotech has announced the start of Phase I trials for its HLX15 proposed daratumumab biosimilar rival to Darzalex. But the Chinese firm is not the only developer chasing the $8bn brand.

Biosimilars Clinical Trials

Sandoz Expects ‘Trough Year’ In 2023 As It Counts Cost Of Spinoff

Sandoz is set for a “trough year” in 2023 as the generics and biosimilars unit faces costs linked with its spinoff from parent company Novartis that will erode its core operating income.

Sales & Earnings Strategy

Amgen Builds Up Future Launches As Oncology Biosimilars Slide

Amgen’s biosimilars sales are on the decline, largely due to erosion of its oncology portfolio. However, the debut of first US Humira rival Amjevita, along with planned versions of Stelara and Eylea, are expected to push the segment back into growth.

Biosimilars Sales & Earnings

Kabi: US Pegfilgrastim Crowd Is An Opportunity For Us, Not A Deterrent

In the second part of Generics Bulletin’s exclusive interview with Fresenius Kabi’s senior vice president for biosimilars in the US, Ali Ahmed, he explains why Kabi is relishing the prospect of competing in pegfilgrastim and what the acquisition of mAbxience means for the company’s prospects and vision.

Biosimilars Manufacturing
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Policy & Regulation Explore this Topic

Set Alert for Policy and Regulation

EMA Clarifies Questions Over Biosimilar Interchangeability

Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.

Biosimilars Regulation

Teva Concedes On US Gimoti ANDA, Voiding 180-Day Exclusivity

Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

Generic Drugs Intellectual Property

FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Intellectual Property Legal Issues

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
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Generic Drugs Explore this Topic

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US Government Proposals Would Obligate Health Plans To Place Generics On Correct Tiers

The HHS and CMS have proposed that health plans in the US be required to place generic and brand drugs on the correct tiers for their drug category.

Generic Drugs Legislation

Teva Concedes On US Gimoti ANDA, Voiding 180-Day Exclusivity

Teva will not engage in paragraph IV patent-infringement litigation with Evoke Pharma over the originator’s Gimoti (metoclopramide) nasal spray treatment for diabetic gastroparesis, following a court order.

Generic Drugs Intellectual Property

FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Intellectual Property Legal Issues
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Biosimilars Explore this Topic

Set Alert for Biosimilars

Advanz Agrees Multi-Market Omalizumab Deal With Alvotech

Advanz and Alvotech have struck a deal that will give Advanz exclusive rights to the biosimilars developer’s Xolair (omalizumab) rival in multiple markets around the world.

Deals Biosimilars

EMA Clarifies Questions Over Biosimilar Interchangeability

Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.

Biosimilars Regulation

Henlius Kicks Off Trial For Darzalex Biosimilar

Shanghai Henlius Biotech has announced the start of Phase I trials for its HLX15 proposed daratumumab biosimilar rival to Darzalex. But the Chinese firm is not the only developer chasing the $8bn brand.

Biosimilars Clinical Trials
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Value-Added Medicines Explore this Topic

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What’s Next? Five Things To Look Out For In February

February brings a potentially sizeable launch in the US, multiple court cases in both the US and Europe and a gala generics and biosimilars event stretching across four days in Florida.

Biosimilars 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

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
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