Tagged as: Adalimumab

Alkem Subsidiary Enzene Launches Adalimumab Biosimilar in India

As reported by HealthCareRadius in India, on February 23, 2023, Enzene Biosciences, a subsidiary of Alkem Laboratories, announced commencement of commercial supplies of its biosimilar adalimumab (ENZ-129) in India to treat ankylosing spondylitis (AS) and rheumatoid arthritis (RA).  This is Enzene’s fourth biosimilar launch in the last eighteen months.  In…

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European Biosimilar Regulatory Updates

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…

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Amgen Launches AMJEVITA—First Biosimilar to HUMIRA in the United States

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,…

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Alvotech and Bioventure Announce Approval of ADALIMUMAB Biosimilar in Saudi Arabia

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…

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Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.”  PwC expects “M&A to more closely resemble prior years with a total deal…

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Samsung Bioepis Announces Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar in Canada

On January 3, 2023, Samsung Bioepis announced that Health Canada has approved their citrate-free, high concentration (40 mg/0.4 mL) HUMIRA biosimilar, HADLIMA (also known as SB5). HADLIMA is indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, adult Crohn’s disease, ulcerative colitis,…

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Fresenius Kabi Announces FDA Approval of Adalimumab Biosimilar

Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA.  IDACIO is approved for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product and, according to Fresenius, is expected to launch in the…

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Alvotech Broadens Access to HUMIRA (adalimumab) Biosimilars

Alvotech announced yesterday the launch of HUKYNDRA, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab), in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia.  Through a strategic partnership with STADA, Alvotech supplies HUKYNDRA (adalimumab) autoinjectors and pre-filled syringes with drug product and drug substance manufactured in its vertically integrated…

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Biocon Biologics Confirms Completion of Multi-Billion Dollar Acquisition of Viatris’ Global Biosimilars Business

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…

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AbbVie’s Q322 Earnings Call Highlights Oncoming Adalimumab Biosimilar Competition

Last week, AbbVie held its third quarter 2022 earnings conference call, which included considerable discussion of forthcoming competition with biosimilars to HUMIRA (adalimumab) in 2023.  Some highlights below: According to Rick Gonzalez, AbbVie Chairman and CEO, “[t]he current market dynamics do not change our long-term guidance for aesthetics and we…

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