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.

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

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.