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On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab) in November 2024 for early Alzheimer’s disease following safety information that ha...

On 28 January 2025, Kashiv Biosciences announced that KSHB002, biosimilar to BMS’ Orencia® (abatacept), met the primary endpoints in its phase 1 clinical trial.  According to Kashiv, the trial demonstrated pharmacokinetic equivalence between KSHB002 and US-licensed and EU-a...

On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer’s disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.  The sBLA fo...

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® and Simponi Aria® (golimumab), which are indicated for a variety of chronic...

On 24 January 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has approved CSL’s Andembry® (garadacimab) for patients aged 12 years and older with hereditary angioedema (HAE) to prevent angioedema attacks.

This makes the UK...

On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab) for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older with C1 esterase inhibitor deficiency or ...

On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey, relating to Celltrion’s biosimilar denosumab.
Amgen had commenced proceedings against Celltrion in May 20...

On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany.
Steqeyma® was launched in France on 20 January 2025, Italy and Spain in ...

On 22 January 2025, Zai Lab announced that the US FDA has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate, for the treatment of small cell lung cancer (SCLC).

According to Zai Lab, the regulatory...

On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won (approx. USD2.78bn), a 23% increase compared to 2023.  According to the Korea Herald, this makes Samsung Biologics t...