On 29 September 2026, the Australian Therapeutic Goods Administration (TGA) approved two aflibercept biosimilars sponsored by Actor Pharmaceuticals: Aflivu® and Ahzantive™. Both brands are approved for all indications of the reference product, Regeneron/Bayer’s Eylea®, in ...
On 28 September 2026, STADA announced that it has entered into an exclusive partnership with Chia Tai Tianqing Pharmaceutical Group (CTTQ), a subsidiary of Sino Biopharmaceutical Limited, for up to four biosimilars. This includes CTTQ’s TQB3570, biosimilar to MSD̵...
On 28 September 2026, Teva announced that it has strengthened its position in the biosimilars market with the FDA approval of its internally developed Degevma™ (denosumab-adet), biosimilar to Amgen’s Xgeva®. Degevma™ is indicated for all approved reference indication...
On 29 September 2026, Sandoz announced the opening of its new high-volume biosimilar drug substance manufacturing centre in Lendava, Slovenia. The opening is a step towards Sandoz’s recently announced Bio100 goal to have more than 100 biosimilars in its portfolio by 2040.<...
On 24 September 2026, Nanexa announced that it has entered into an exclusive global licence and collaboration agreement with Novo Nordisk for the development of long-acting injectable formulations of Novo Nordisk’s products using Nanexa’s PharmaShell® drug deliv...
On 24 September 2026, Eli Lilly announced that the FDA has approved Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for treatment of type 2 diabetes in adults. It is indicated for use as an adjunct to diet and exercise to control high blood suga...
On 23 September 2026, Mylan filed a Complaint in the US District Court for the District of Delaware seeking a declaration of non-infringement and invalidity in relation to Novo Nordisk’s U.S. Patent No. 12,551,536. The patent was granted on 17 February 2026 and relates to ...
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 18 September 2026 are set out b...
On 21 September 2026, Sandoz Group AG joined the Swiss Market Index (SMI), Switzerland’s leading blue-chip equity index. The milestone was foreshadowed in an announcement by Sandoz on 9 July 2026 and comes less than three years after Sandoz became an independent publicly l...
On 21 September 2026, Roche announced that the European Commission (EC) has approved Susvimo® (ranibizumab) as a 100 mg/mL solution for injection for the treatment of neovascular age-related macular degeneration (nAMD).
The European approval follows the CHMP’s positi...
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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