Strategy

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.

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.

With just 14% of active pharmaceutical ingredients estimated to be made in the US and China’s overall dominance in the space, a new study points to the pressing need for the US to address bottlenecks in the supply chain and proposes a string of approaches to partner with India in its de-risking efforts.

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.

The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits.

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. 

With Teva and Viatris recently under new management and Sandoz having last year split from former parent company Novartis, the three off-patent industry leaders are adopting different strategies for how they balance their generics and biosimilars interests with more innovative ventures. Generics Bulletin takes a look at the bigger picture.

It’s been a year since Biogen made it clear that it was ready to put its biosimilars business on the market. But despite signaling interest in the unit from multiple potential suitors over the past 12 months, the firm says it hasn’t yet received any “acceptable” offers, and may retain it after all.

Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.

With a focus on drug accessibility, supply chain resilience, and a balanced approach to sustainability, Medicines for Ireland “calls to action” with its five-year plan.

A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.

Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.

Alvotech’s high confidence for FDA approval for its Stelara biosimilar has been justified, as the Icelandic firm announced only the second US approval for a rival to J&J’s Stelara powerhouse brand, ahead of market formation in 2025.

In the second part of an exclusive interview, Formycon CEO Stefan Glombitza talks to Generics Bulletin about key regulatory developments in Europe and the US, the firm’s portfolio selection strategy, and upcoming milestones on the horizon.

Characterizing biosimilars as a global movement towards the democratization of medicine, Formycon CEO Stefan Glombitza speaks to Generics Bulletin in detail about the company’s recent deals, launches and key pipeline assets, in the first part of an exclusive two-part interview.

Switzerland and Canada mark the first market entries for Formycon’s ranibizumab biosimilar this year, with several anticipated launches in the Middle East later in 2024.