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Fresenius Kabi announced it has launched Tyenne®, the first EC-approved biosimilar to Roche’s Actemra®/RoActemra® in the EU.  Tyenne® was approved by the EC on 19 September 2023 to treat rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis...

MSD announced that the US FDA has approved Keytruda® (pembrolizumab) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC), in combination with gemcitabine and cisplatin.  This brings the total number of US approved gastro...

Amgen announced in its Q3 2023 results that the FDA has accepted its Biologics License Application (BLA) for ABP 938, its biosimilar to Regeneron’s Eylea® (aflibercept).  Amgen did not include the FDA target action date in its announcement.

On 29 August 2023, the FDA...

On 31 October 2023, the FDA approved Amgen’s Wezlana® (ustekinumab-auub), as the first FDA-approved biosimilar to Janssen’s Stelara®.  Wezlana is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis (each in both adults and paedia...

Novartis announced that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults.

On 27 October 2023 the National Institute for Health and Care Excellence (NICE) recommended Cosentyx® for moderate to severe HS.

A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa (Binocrit®), etanercept (Erelzi®), filgrastim (Zarzio®), infliximab (Zessly®), pegfilgrastim (Ziextenzo®), rituximab (Rixathon®), and somatropin (Omnitrope®) “ca...

The FDA has approved Bristol Myers Squibb’s supplemental biologics license application (sBLA) for subcutaneous use of Orencia® (abatacept) to treat juvenile psoriatic arthritis (JPsA) in patients aged two and older.

On 1 November 2023, changes introduced following th...

Aragen announced it is establishing a new US$30M, 160,000m2 biologics manufacturing site in Bangalore, India.  The facility will include multiple GMP manufacturing suites, quality control and process development labs, and downstream purification capabilities.

On 12 O...