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Biosimilars

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

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

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

Fresenius Kabi And Formycon Ally On Stelara Rival

Fresenius Kabi and Formycon have announced a global licensing deal for the FYB202 ustekinumab proposed biosimilar rival to Stelara. The deal comes as Formycon has revealed plans to raise further funds to funnel into research and development through a fresh share issue.

Deals Biosimilars

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

Adalimumab Expectations Revised In The Wake Of Amgen Launch

The launch of Amgen’s Amjevita, the first US biosimilar rival to Humira, has been accompanied by multiple fresh forecasts of how competition could play out this year, with a host of further biosimilar launches on the horizon.

Biosimilars United States
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