Speaking at Medicines for Europe’s 20th annual biosimilar medicines conference, Isabell Remus, chair of Medicines for Europe’s biosimilar medicines sector group, looks to the future for European biosimilars over the next decade and outlines the potential that can be realized – but only if a comprehensive strategy for biosimilars is put in place.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

The FDA and EMA have shared perspectives on the parallel scientific advice pilot for complex generics. Now industry stakeholders discuss whether transatlantic convergence is possible or merely a good idea on paper.

The approval brings another biosimilar to Amgen’s Neulasta, stepping up competition in an already heated market that has seen major approvals in the past year.

 The US off-patent association published an analysis of IQVIA data, which highlights the role of rebate schemes that is slowing the adoption of Humira biosimilars that would save billions of dollars.

The timing of the request, with Xtandi’s loss of exclusivity on the horizon, could be explained by the concern that a change in the US presidential administration in 2025 may limit the prospects for near-term relief.

Price increases from multiple suppliers pushed vardenafil to the top of our Biggest Risers table for March 2024.

Policy may be helpful in promoting acceptance of follow-ons in Medicare but is not expected to result in near-term savings to the program.

More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case.

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

Vanda looks likely to have to face up to unimpeded US generic competition to its core Hetlioz brand, after a further denial in its litigation against ANDA sponsors Teva and Apotex.

Lupin and Zydus are targeting a market worth at least $1bn a year – and more than $2.4bn all told – after both in quick succession announcing the launch of generic versions of Astellas Pharma’s Myrbetriq treatment for overactive bladder.

Cigna’s Evernorth has announced plans to make a Humira biosimilar available for $0 out-of-pocket for Accredo patients from June, adding to momentum for adalimumab rivals from previous policy changes made by CVS in recent weeks. Meanwhile, AbbVie has offered the latest on how competition to its once top-selling brand is ramping up.

After getting off to a slow start last year, US biosimilar rivals to Humira are beginning to gain more traction. Sandoz is increasing its share on a weekly basis, Alvotech and Teva have struck a deal for their newly-approved interchangeable 100mg/ml biosimilar, and the latest market data shows biosimilars capturing twice as much of the market in Q1 as in Q4 2023.

 The US off-patent association published an analysis of IQVIA data, which highlights the role of rebate schemes that is slowing the adoption of Humira biosimilars that would save billions of dollars.

Price increases from multiple suppliers pushed vardenafil to the top of our Biggest Risers table for March 2024.