On 1 March 2025, Sandoz’s high-concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) 100mg/mL (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira®
On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of Bristol Myers Squibb’s US patents relating to methods of treatment using nivolumab and…
At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the following six biopharmaceuticals.
On 28 February 2025, Biocon announced that it has launched its liraglutide products in the UK. The products are generic versions of Novo Nordisk’s Victoza®, to treat type 2 diabetes, and Saxenda®,
On 28 February 2025, Regeneron announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation of Lynozyfic® (linvoseltamab)
On 28 February 2025, Biogen and Eisai announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for Leqembi® (lecanemab) for early Alzheimer’s disease.
On 28 February 2025, Outlook Therapeutics announced that it has resubmitted its Biologics Licence Application (BLA) to the US FDA for ONS-5010 (Lytenava™, ophthalmic bevacizumab-vikg) for the
On 26 February 2025, Regeneron announced that the US FDA has accepted for review the resubmission of the BLA for odronextamab for the treatment of relapsed/refractory follicular
On 26 February 2025, CSL announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Andembry® (garadacimab) for long-term prophylaxis of recurring attacks of hereditary angioedema (HAE) in adult and certain paediatric patients.
On 25 February 2025, Merck (known as MSD outside the US and Canada), published its 2024 Annual Report, which revealed the company’s expectation that Keytruda® (pembrolizumab) will be selected in 2026 for government price setting
On 25 February 2025, Merck (known as MSD outside the US and Canada) announced that the US FDA has accepted for priority review a Biologics Licence Application (sBLA) for Keytruda® (pembrolizumab)
On 25 February 2025, Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Sarclisa® (isatuximab), in combination with bortezomib, lenalidomide, and
On 25 February 2025, Formycon and Klinge Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ahzantive®/FYB203 (aflibercept),
On 24 February 2025, Sandoz announced the US launch of Pyzchiva® (ustekinumab-ttwe), biosimilar to J&J/Janssen’s Stelara®. On the same date, Biocon Biologics announced the US launch of Yesintek™ (ustekinumab-kfce/Bmab 1200).
On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence agreement entered in July 2023 (announced in November 2023
On 24 February 2025, Celltrion announced that European Commission has approved Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab). Avtozma® is approved for all indications of