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On 3 February 2025, Johnson & Johnson (J&J) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended an indication extension for its subcutaneous Rybrevant® (amivantamab):

in combination with...

Shanghai Henlius Biotech announced on 2 February 2025 that the US FDA has accepted its Biologics Licence Application (BLA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).

The US acceptance of Henlius’ BLA follows the December 2024 acceptance of its NDA for HL...

On 31 January 2025, Celltrion announced that the US FDA has approved its Avtozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in both subcutaneous and intravenous formulations for several indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA)...

On 31 January 2025, Sanofi announced that China’s National Medical Products Administration (NMPA) has approved Sanofi’s Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed mul...

On 31 January 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published the outcomes considered at its December 2024 intracycle meeting.

Abbvie’s Humira® (adalimumab) received a number of recommendations, including:

new PBS listings for e...

On 30 January 2025, Judge Hacon of the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) is valid and infringed by Celltrion.

The decision was delivered in a proceeding commenced by Celltrio...

On 30 January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with relapsed or r...

At its January 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for four new medicines and expanded indications for eight.

The new medicines include AstraZeneca/Daiichi Sa...

On 30 January 2025, Amgen’s Pavblu® and Skojoy®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).  The two biosim...

On 29 January 2025, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Hympavzi™ (marstacimab) in 150mg/mL solution for injection, prefilled pen, indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with: severe h...