Pearce IP BioBlast w/e 10 May 2024

On 10 May 2024, Xbrane and Stada announced the exclusive licensing agreement with US biosimilars specialist Valorum Biologics for their ranibizumab biosimilar candidate.

Swedish biosimilar developer Xbrane and Germany’s STADA are responsible for completing the regulatory approval process for the ranibizumab candidate, and Xbrane is responsible for commercial manufacturing and supply. Valorum will be responsible for US commercialisation efforts for the product which is expected to be supplied as Lucamzi™.

On 21 April 2024, Xbrane announced that the FDA issued a Complete Letter Response regarding its ranibizumab BLA. Xbrane has not yet announced a resubmission date for the BLA.

On 9 May 2024, Rani Therapeutics announced that it will present pre-clinical and clinical data at Digestive Disease Week in the US (18-21 May 2024) regarding RT-111, an oral delivery platform known as the RaniPill® capsule, containing Celltrion’s ustekinumab biosimilar, CT-P43 (biosimilar to Janssen’s Stelara®).  The title of one of the abstracts to be presented suggests that the RaniPill® was found to reliably and safely deliver ustekinumab with high bioavailability relative to subcutaneous ustekinumab in healthy human participants.

On 5 February 2024, Rani Therapeutics published positive topline results from a phase 1 clinical trial of RT-111.  In June 2023, Rani expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar (RT-105), in addition to RT-111.

On 8 May 2024, Telix announced an agreement with Cardinal Health Nuclear & Precision Health Solutions for the global clinical supply of actinium-225 (Ac-225). This therapeutic radioisotope will support the development of Telix’s targeted alpha therapy (TAT) pipeline.

On 7 May 2024, the EU Medicines Agency (EMA) withdrew marketing authorisation (MA) approval for AZ’s COVID-19 vaccine Vaxzevria, at AZ’s request. AZ requested the withdrawal reportedly due to decline in demand for the vaccine and it no longer being manufactured or supplied.

Vaxzevria was co-developed with Oxford University as a Covid-19 vaccine and was manufactured by CSL. Vaxzevria was granted conditional MA for immunisation against Covid-19 on 29 January 2021 and then granted a 5-year standard MA on 31 October 2022. According to CNN Business, AZ has supplied more than 3 billion vaccine doses globally since 2021.

On 7 May 2024, Pharma In Focus reported that Arrotex has partnered with Amgen to promote Amgen’s Prolia® (denosumab) in Australia.  It is planned that the partnership “will support the future growth of Prolia in the Australian market, utilising the infrastructure and reach of Arrotex to further the patient, pharmacist and prescriber experience”.  It is unclear when the agreement will take effect.

There are no Prolia® (denosumab) biosimilars approved in Australia to date.  Prolia® biosimilars have been approved in the US (Sandoz’s Jubbonti®, March 2024), Canada (Jubbonti®, February 2024) and China (Boan Biotech’s Byoubei® (November 2022) and Mabwell’s Mailishu® (March 2023)).

On 7 May 2024, Sandoz announced Q1 2024 net sales of USD1.9 billion, with its biosimilars growing 21% to USD 623 million.  The biosimilar growth is said to be driven by Sandoz’s 2023 US/EU launch of Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab), and the acquisition of Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), announced in January 2024.  During the reported quarter, Sandoz also launched in Germany the Polpharma-developed Tyruko® (Biogen’s Tysabri®, natalizumab) and obtained US approval for Jubbonti® and Wyost® (Amgen’s Prolia®/Xgeva®, denosumab).