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On 1 October 2025, Biocon announced that it has entered into a settlement and licence agreement with Amgen that resolves pending BPCIA patent litigation and permits Biocon’s 1 October 2025 US launch of Bosaya™ and Aukelso™ (denosumab-kyqq), biosimilars to Amgen’s Prolia® an...

On 1 October 2025, the US Patent Trial and Appeal Board (PTAB) issued its decision in the inter partes review (IPR), filed by Amgen in February 2025 and instituted in July 2025, challenging the validity of BMS’ US patent US11332529 (‘529) relating to methods of treating col...

On 1 October 2025, Sandoz’s Erelzi®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 50mg/mL syringe and pen devices.

Erelzi® is the third etanercept biosimilar to be PBS-listed (approved November 2...

On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for Conexxence® and Bomyntra®, biosimilars to Regeneron/Bayer’s Prolia® and Xgeva® (denosumab), respectively.  This will provide a s...

On 29 September 2025, Gedeon Richter and Hikma Pharmaceuticals announced they have secured FDA approval for Enoby™ (RGP-14-P) and Xtrenbo™ (RGP-14-P) (denosumab-qbde), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.

Hikma and Richter entered into...

On 29 September 2025, Outlook Therapeutics announced that it has completed a Type A Meeting with the FDA to discuss the August 2025 complete response letter (CRL) declining Outlook’s BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet...

On 29 September 2025, Genmab A/S and Merus N.V. announced that they have entered into an agreement for Genmab to acquire all the shares of Merus in an all-cash transaction worth approximately USD 8 billion, with the deal anticipated to close early in the first quarter of 20...

On 29 September 2025, Novartis announced that it plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from 1 November 2025, offering cash-paying patients access to the drug at 55% off the list price.

According to Novartis, Cosentyx® is it...