Australia

Sandoz and Alvotech have struck a deal that will see the firms collaborate on multiple biosimilar candidates for the Australian, Canadian and New Zealand markets across therapeutic areas including ophthalmology, immunology and gastroenterology.

A deal for the Duchenne muscular dystrophy treatment with Nxera is valued at up to $205m.

Joint Singapore-UK plan underlines direction of travel for MHRA after its embracing of international reliance (IR). Australia’s TGA has also broken new ground by recognizing the UKCA mark.

Treasurer Jim Chalmers has blocked the AU$677m bid following FIRB advice that the acquisition posed unacceptable risks to Australia’s critical medicine supply chains.

The trade body, Medicines Australia, has flagged a downturn in new drug launches, attributing it to the effects of President Trump’s trade policies. It has called for “urgent action.”

The culmination of the MedTech Innovator APAC awards program 2025 comes later this month when the top prizes are handed out at the grand final in Singapore. But all cohort companies benefit from the competition’s mentoring process, says awards organizer Fredrik Nyberg.

Formycon and its aflibercept biosimilar partner Klinge shook hands with Actor Pharmaceuticals and Megalabs to market the Eylea rival in their respective regions.

APACMed 2025 delegates heard how two global device regulators have shifted to a policy of early advice for innovators, with benefits for all industry stakeholders.

Sandoz has been given the go-ahead to introduce the first biosimilar to Eylea in Australia following a favorable court ruling denying a temporary injunction.

With needed funds in its pocket, Serina is set to advance its apomorphine therapy, which was developed with a proprietary delivery technology.

Arrotex has entered into a strategic partnership with Celltrion Healthcare Australia to launch two first-to-market biosimilar medicines in Australia. These biosimilars, which treat chronic inflammatory conditions, are now listed on the PBS and available through pharmacies.

Neuraxpharm has launched its Australian affiliate as part of its continued international expansion beyond Europe. The company will introduce CNS treatments including its acquired Nuvigil, Provigil, and the recently TGA-approved Briumvi for multiple sclerosis.