Biosimilars

Amneal has joined the ranks of generics manufacturers who had to pay millions to settle legal claims linked to the sector’s alleged role in the US opioid epidemic.

Updated draft guidance on promotion of biologic reference products, biosimilars and interchangeable biosimilars offers another indication of the US’s push to do away with the interchangeability designation.

With Sandoz delivering first-quarter growth thanks to its booming biosimilars business – and despite flat sales of small-molecule generics that suffered from a downturn in North America – the company is “well on track to surf the biosimilars wave,” according to one analyst. However, Sandoz did report a delay to progress with its natalizumab biosimilar in the US that will push back launch.

The Chinese biotech reported increased growth in its revenue fuelled by its portfolio of biologic drugs and biosimilars, with further plans for approvals around the world.

Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.

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.

Pfizer has reported US oncology biosimilars sales that were down by 47% in the first quarter of 2024, as pricing pressures took their toll.

A second tocilizumab biosimilar has been launched in the US, with Bio-Thera and Biogen together introducing their Tofidence version just weeks after Fresenius Kabi launched its first-to-market Tyenne.

Amgen has revealed a program for a biosimilar rival to Keytruda, as it reported Q1 results that saw its biosimilars business grow by more than a tenth.

Lupin has pushed into the Canadian biosimilars market with the launch of its Rymti rival to Amgen’s Enbrel. The launch is taking place via Lupin’s local partner Sandoz.

Celltrion unveils its agreement with the PBM Express Scripts that will place its Zymfentra subcutaneous infliximab on its preferred formulary after alluding to the deal in an earlier notice. 

In a podcast discussion, Generics Bulletin’s editors talk about how you can enter and attend the Global Generics & Biosimilars Awards, what makes for a good entry, and why companies and individuals will want to get involved in the event.

The US FDA has marked a milestone with the approval of the country’s 50th biosimilar, in the form of Henlius and Accord BioPharma’s Hercessi trastuzumab rival to Herceptin.

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

Teva and Alvotech have confirmed deductions that it is their recently-approved 100mg/ml adalimumab biosimilar that will be used by Cigna’s Evernorth as part of a recently announced private-label deal involving Evernorth’s Quallent Pharmaceuticals.

Formycon has shared its results for 2023, reporting revenue growth and exceeding projections for its working capital, as the company prepares for approvals in the coming year.