DataZymes Biosimilars

ASCO 2024 #ConferenceCoverage #DataZymes

Sandoz has received European Commission (EC) approval for its marketing authorization application for Pyzchiva, a biosimilar referencing Johnson & Johnson's Stelara. The biosimilar was developed and registered by Samsung Bioepis. Pyzchiva is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy. Pyzchiva is approved as a biologic therapy within gastroenterology, dermatology, and rheumatology. Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK. https://lnkd.in/dBMx_ESS

An approval roundup across three major markets, US, EU and Japan.

CuraTeQ Biologics' Xolair biosimilar, BP11, has successfully met the primary endpoints of the Phase I study, comparing BP11 with US and EU sourced Xolair. The PK/PD Omalizumab trial was conducted in 165 healthy volunteers in Australia and New Zealand, with the primary objective of proving pharmacokinetic (PK) equivalence between BP11 and US and EU sourced Xolair. CuraTeQ Biologics has initiated two Phase III studies across Europe for chronic spontaneous urticaria and in India for asthma, with the aim of achieving regulatory approval in India by 2024 and in regulated markets by 2025. https://lnkd.in/d8yqmRUc

Celltrion USA today announced that the company has submitted a Biologics License Application (BLA) for CT-P39, an interchangeable biosimilar referencing Novartis/ Roche's Xolair (omalizumab) to the US FDA. The application for CT-P39 includes all the indications for which Xolair is approved for, including asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) and chronic spontaneous urticaria. The filing from Celltrion USA marks the first submission for a Xolair biosimilar in the US. It is also interesting to note that ambiguity around the interchangeable status and its market implications in the US, has not stopped biosimilar manufacturers from seeking it. Recently Sandoz and Amgen, also received FDA approval for interchangebale biosimilars of Prolia and Stelara respectively. https://lnkd.in/dCHwwJPv

The FDA has approved Sandoz's Wyost and Jubbonti, the first biosimilars to and interchangeable with Amgen's Xgeva and Prolia, respectively. The approval is based on robust clinical studies and a totality of evidence, which shows no clinically significant differences from the reference medicines. Wyost and Jubbonti will be available as single-dose prefilled syringes containing 60mg/1mL solution and are approved for all indications of the reference medicines Xgeva and Prolia. Sandoz has not currently disclosed any timelines for the launch of products due to the ongoing patent litigation. https://lnkd.in/gY9FcxnE

On Thursday, Biocon announced a patent settlement with Janssen Inc. for its Stelara biosimilar. With this deal, Biocon will be launching its Bmab 1200, a biosimilar referencing Stelara, in February 2025, subject to FDA approval. Biocon's BLA for Bmab 1200 has already been accepted by the FDA for review under the 351(k) pathway. With this agreement, Biocon joins a list of other biosimilar competitors including Amgen, Alvotech/Teva Pharmaceuticals, Samsung Bioepis/Sandoz, Celltrion Inc, Formycon AG/Fresenius Kabi, and Dong-A Pharmaceutical Co.,Ltd/Accord Healthcare, all of whom have launch dates for their respective biosimilar products slated for the first half of 2025. Stelara, introduced in 2009, has been Janssen Inc.'s top-selling drug since 2019, with sales reaching $7 billion in 2023 and is expected to contribute significantly to the company's projected $57 billion revenue by 2025. https://lnkd.in/ddQwnNpq

Alvotech has received FDA approval for Simlandi, the first interchangeable high concentration biosimilar referencing AbbVie's Humira, for the treatment of multiple autoimmune conditions. Simlandi is also eligible to win a one-year market exclusivity. Alvotech and its US commercial partner Teva Pharmaceuticals, plan to launch Simlandi in the near future in the US The companies plan to take a multi-part approach for marketing the product: 1) In addition to benefits of being an HC-IC formulation, Alvotech has also made investments in manufacturing infrastructure even before receiving approvals, to ensure a steady supply of the product 2) Furthermore, Alvotech has also invested significant time and effort to make its autoinjector as patient-friendly as possible. If granted exclusivity in the US, Simlandi may stall the launch of proposed HC-IC biosimilars by Amgen and Samsung Bioepis/Organon which are currently under review. https://lnkd.in/d7f8rDc8

Coherus BioSciences announced the successful launch of its innovative on-body injector (OBI) Udenyca, now available under the brandname UDENYCA ONBODY across the US. This innovative OBI presentation is accessible through a widespread nationwide distribution network, ensuring convenient access for patients.   UDENYCA ONBODY offers an array of cutting-edge features aimed at enhancing the patient experience including a 5-minute delivery timeline. Additional features include an intuitive indicator, status light, and auditory signal, empowering patients to confidently confirm the successful administration of their dose and a strong, well-tolerated adhesive. The automatic retraction of the needle post-administration, adds an extra safety layer by significantly reducing the risk of needlestick injuries and enhancing overall patient safety. https://lnkd.in/deTy4b4v