Biosimilars

Fresenius Kabi is drawing closer to the conclusion of its Vision 2026 strategic roadmap. The company’s CEO, Pierluigi Antonelli, talks to Generics Bulletin about the company’s results so far and how it’s investments in biosimilars, acquisitions and manufacturing is paying off.

Generics Bulletin reviews global regulatory developments across the globe.

Sweden’s Xbrane has struck a deal to transfer its R&D operations in Sweden and its Cimzia (certolizumab pegol) biosimilar candidate to Alvotech, in a transaction worth around $27m. However, Xbrane told Generics Bulletin that it was not getting out of biosimilar development altogether.

With Sandoz set to debut US competition to Prolia and Xgeva in a matter of months, other biosimilar sponsors are working hard to ensure launch of Amgen’s blockbuster in a timely manner.

IGBA secretary general Susana Almeida takes Generics Bulletin through an almost two-decade journey of developing global regulatory convergence and the next goals for the off-patent industry.

Roche is in the crosshairs of the Belgian Competition Authority for allegedly delaying the entry of rituximab and trastuzumab biosimilars between 2017 and 2020, after the BCA sent the firm a statement of objections over “exclusionary practices.”

Stada has set out annual results that it says demonstrate that the German firm is outperforming the market in all of its business segments, with the company breaking the €4bn sales barrier for the first time. The results come ahead of a long-awaited potential IPO that conflicting rumors suggest could either come very soon indeed, or may be delayed until later this year.

Fresenius Kabi has become the latest biosimilar sponsor to settle US litigation with Amgen over its Prolia/Xgeva rivals. The German firm revealed to Generics Bulletin details of launch dates for its denosumab in both the US and Europe.

Amgen’s biosimilar aflibercept formulation is keeping it head and shoulders above other would-be Eylea biosimilar competitors, while continuing to frustrate originator Regeneron’s push to block sales of the product while it battles Amgen over alleged infringement of a key US patent.

Biocon Biologics is partnering with Civica to supply insulin aspart drug substance that will be used for final US manufacturing by Civica at its plant in Petersburg, Virginia.