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…
According to news reports, Celltrion recently launched VEGZELMA (bevacizumab) in Japan. In September 2022, the drug received sales approval from the Japanese Ministry of Health, Labor and Welfare for the treatment of metastatic colorectal cancer, non-small cell lung cancer, and more. Japan is home to the world’s second largest bevacizumab…
Amgen announced today the launch of AMJEVITA (adalimumab-atto), a biosimilar to AbbVie’s HUMIRA (adalimumab), in the United States. AMJEVITA was the first HUMIRA biosimilar approved by the FDA and is now the first to be launched in the United States. AMJEVITA is approved to treat seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis in adults,…
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…
Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of claims 1-18 of U.S. Patent No. 10,464,992 (“the ’992 patent”), assigned to Regeneron Pharmaceuticals, Inc. According to the Petition, the challenged claims of the ’992 patent “encompass a formulation comprising the VEGF inhibitor protein, aflibercept, which Regeneron markets…
Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to biosimilars, an American problem.”[1] The article, published in the Journal of Law and the Biosciences, examines whether patent…
On January 24, Alvotech and Bioventure, a subsidiary of GlobalOne Healthcare Holding LLC, announced that the Saudi Food & Drug Authority has approved SIMLANDI, a biosimilar referencing HUMIRA (adalimumab), in Saudi Arabia. According to the press release, Bioventure is Alvotech’s exclusive strategic partner for the commercialization of SIMLANDI in the…
On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint. As we previously reported, Genentech filed a complaint against Tanvex in June 2022, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA…
This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab). BAT1806 is approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS), and is the first tocilizumab biosimilar approved by any…
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,…