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On 26 August 2024, Regeneron filed a BPCIA complaint against Sandoz in the US District Court for the District of New Jersey, asserting infringement of 46 US patents relating to aflibercept.  The filing came two weeks after the FDA approved Sandoz’s Enzeevu™ (aflibercept-abz...

Shanghai Henlius Biotech has revealed its financial results for the first half of 2024, reporting revenue of RMB2.7461 billion (an increase of 9.8% YOY) and a record net profit of RMB2.7461 million (an increase of 61% YOY).

Henlius attributes its profits to increasin...

On 26 August 2024, Insulet Corporation announced that it received FDA approval for its Omnipod® 5 Automated Insulin Delivery (AID) System  for use in the US by people with type 2 diabetes (ages 18 years and older).

The Omnipod® 5 is a wearable device which provides u...

JAMP recently filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab).  JAMP alleges that Janssen has abused its dominant market position, in contravention of section 79 of the Com...

On 23 August 2024, the US FDA approved Amgen’s Pavblu™ (ABP 938, aflibercept-ayyh), biosimilar to Regeneron’s Eylea® (aflibercept), for nAMD, macular oedema following RVO, diabetic macular oedema and diabetic retinopathy.

Pavblu™ is the fifth aflibercept biosimilar t...

On 23 August 2024, Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved in Australia.  These are the first denosumab biosimilars approved in Australia.

This follows a number of denosumab biosimila...

On 23 August 2024, Indian-based Lupin announced that its Armlupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) received approval from Health Canada.  Armlupeg® is available in a pre-filled syringe of 6mg/0.6 ml.

This approval comes over 6 years after the first p...

On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.

The following biosimilars were recommended...

On 22 August 2024, Pfizer Canada announced that Padcev® (enfortumab vedotin) in combination with MSD’s Keytruda® (pembrolizumab) has been approved by Health Canada for treatment of unresectable locally advanced or metastatic urothelial cancer (la/mUC) with no prior systemic...

On 22 August 2024, Shanghai Henlius Biotech announced that its partner, Intas subsidiary Accord Healthcare, has received marketing approval from Health Canada for HLX02, the Henlius-developed biosimilar to Roche’s Herceptin® (trastuzumab) to treat early/metastatic breast ca...