Alteogen Inc. announced that it entered an exclusive license agreement with Sandoz AG pursuant to which Sandoz will have world-wide rights to use Alteogen’s ALT-B4 hyaluronidase, derived using Hybrozyme™ Technology, to develop and commercialize a subcutaneous version of a Sandoz biosimilar product. Sandoz also has an option to license the Hybrozyme™…
The US FDA has accepted a Biologics License Application (BLA) from Sandoz for a proposed denosumab biosimilar. In its press-release, Sandoz stated that the “application includes all indications covered by the reference medicines Prolia® (denosumab)* and Xgeva® (denosumab)* for treating a variety of conditions, including osteoporosis in postmenopausal women and…
Big Molecule Watch monitors for biosimilar clinical trial results. Here we report on four recent announcements concerning biosimilars of natalizumab, trastuzumab, daratumumab, and aflibercept. On January 23, 2023, researchers published the results of a phase III clinical trial demonstrating that PB006, Polpharma Biologics SA’s biosimilar to Biogen’s approved treatment TYSABRI®…
STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) has granted marketing authorization for XIMLUCI (ranibizumab), a biosimilar of LUCENTIS. XIMLUCI is an anti-VEGF (vascular…
On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA and USPTO have been working together to leverage their combined expertise to promote competition and access…
This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma. Celltrion has secured sales licenses for Vegzelma in 35 countries,…
On Jan 6, 2023, Alvotech and Teva announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab), and stated that the companies anticipate that the FDA’s review will be completed in the second half of 2023. In August 2020,…
As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of its acquisition in a part-cash/part-equity transaction. Under the terms of this USD $3.335 billion deal, Biocon paid…
Luye Pharma Group announced last week that China’s National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures. Luye Pharma Group, in conjunction with its subsidiary Boan Biotech, is now the first company in the world to receive…
On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s LUCENTIS. XIMLUCI is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders and has been approved…