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16 May 2025 Danish diabetes and weight loss juggernaut Novo Nordisk is to part ways with its chief executive Lars Fruergaard Jørgensen as the group seeks to reverse its fortunes.
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Biosimilars
The US Food and Drug Administration’s (FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. 16 May 2025
Biosimilars
Teva Pharmaceutical Industries’ US subsidiary and Iceland-based Alvotech (Nasdaq: ALVO) today announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). 5 May 2025
Biosimilars
Swiss generics and biosimilars major Sandoz has signed a global collaboration with Shanghai Henlius Biotech to commercialize a biosimilar of leading oncology therapy, ipilimumab, the active ingredient of Bristol Myers Squibb’s blockbuster drug Yervoy. 30 April 2025
Biosimilars
South Korea’s Samsung Bioepis today released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC) of the commercially available biosimilars in the USA, as well as the price and market share trends since each biosimilar’s launch. 24 April 2025
Biosimilars
Physician attitudes toward patient choice between the use of biologics and biosimilars vary widely across global markets, revealing deep-rooted cultural and systemic differences. 22 April 2025
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologics has announced a settlement and license agreement with the USA’s Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the USA. 17 April 2025
Biosimilars
China’s Chime Biologics has formed a strategic partnership with European biosimilars specialist Polpharma Biologics to support the end-to-end development and manufacture of a biosimilar product targeting the global market. 16 April 2025
Biosimilars
Innovent Biologics has recently received approval for Sycume (teprotumumab biosimilar) to treat thyroid eye disease (TED) in China, making it the country’s first insulin-like growth factor 1 receptor (IGF-1R) monoclonal antibody cleared for TED by the National Medical Products Administration (NMPA). 16 April 2025
Biosimilars
The US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s mega blockbuster drug Humira (adalimumab), to treat eight conditions, including Crohn's disease and ulcerative colitis. 15 April 2025
Biosimilars
Shares of California-based Coherus BioSciences (Nasdaq: CHRS) rose more than 5% to $0.88 in pre-market activity today as it completed a transformative transaction. 14 April 2025
Biosimilars
Swiss generic and biosimilar medicines firm Sandoz today announced it has filed an antitrust lawsuit in the USA against Amgen for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. 14 April 2025
Biosimilars
South Korea’s Samsung Bioepis presented data, including the budget impact analysis on ustekinumab biosimilars’ cost savings in Germany, the UK and Sweden at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea. 10 April 2025
Biosimilars
Israel-based Teva Pharmaceuticals industries today revealed two important updates reflecting its commitment to expanding access to both biosimilars and innovative medicines. 7 April 2025
Biosimilars
An Expert View from Dr Elena Wolff-Holz, global head of clinical development at Biocon Biologics, the biosimilar subsidiary of Biocon. 7 April 2025
Biosimilars
The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. 2 April 2025
Biosimilars
China's Bio-Thera Solutions has entered into an exclusive commercialization agreement with India's Dr Reddy's Laboratories for two proposed biosimilars referencing Stelara (ustekinumab) and Simponi (golimumab). 1 April 2025
Biosimilars
South Korea’s Celltrion has announced the US launch of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), following approval by the US Food and Drug Administration (FDA) in December 2024. 13 March 2025
Biosimilars
US pharma major Bristol Myers Squibb has announced positive data from the pivotal Phase III POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 10 March 2025
Biosimilars
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
Biosimilars
Swiss generics and biosimilars giant Sandoz today announced financial results for the full year 2024, showing that sales were $10.4 billion, up by 9% in constant currencies (+7% in $). 5 March 2025
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Biosimilars
Germany-headquartered drugmaker Fresenius Kabi has announced the US launch of Stimufend (pegfilgrastim-fpgk), a biosimilar to Neulasta (pegfilgrastim), for use in patients at risk for febrile neutropenia, a common side effect of many anti-cancer medications. 17 February 2023
Biosimilars
Similis Bio, the JSR Life Sciences business unit focused on biosimilar development, has announced plans to enter into a partnership with Novel351k. 16 February 2023
Biosimilars
The advent of biologics has opened doors for the treatment of several acute and chronic medical conditions.1 Unlike conventional medicines, biologics are derived from living organisms using complex biomedical processes. As a result, development of biologics is more complicated as compared to conventional drugs.2 14 February 2023
Biosimilars
Icelandic firm Alvotech and marketing partner German drugmaker STADA Arzneimittel today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab). 9 February 2023
Biosimilars
Róbert Wessman, founder and chairman of Icelandic biosimilars company Alvotech and investment fund Aztiq, offers his vision for affordable global healthcare in an Expert View piece. 7 February 2023
Biosimilars
The American business of South Korea's Celltrion Healthcare has appointed Thomas Nusbickel as chief commercial officer. 7 February 2023
Biosimilars
Privately-held Advanz Pharma has announced that it has entered into an exclusive agreement with Alvotech, an Icelandic biosimilars company, for the exclusive license and supply rights for a proposed copy of Xolair (omalizumab). 6 February 2023
Biosimilars
Sandoz, the generics and biosimilars business unit of Swiss pharma giant Novartis that is soon to be spun out, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab. 6 February 2023
Biosimilars
Two decades and more than $200 billion later, AbbVie has finally lost its exclusive hold on the US market for biologics based on Humira (adalimumab). 31 January 2023
Biosimilars
Biologic products have revolutionized the treatment options for many diseases and typically carry favorable benefit–risk profiles compared with small molecule drugs. 31 January 2023
Biosimilars
The US Food and Drug Administration (FDA) has released the BsUFA III Regulatory Science Pilot Program: Research Roadmap. 26 January 2023
Biosimilars
Indian drugmaker Dr Reddy’s Laboratories has completed the trial program for its proposed rituximab biosimilar candidate, and will move ahead with global regulatory interactions. 23 January 2023
Biosimilars
Adding to European Commission clearance in November last year, German drugmaker STADA Arzneimittel and Sweden’s Xbrane Biopharma announced that their Ximluci (ranibizumab), a biosimilar referencing Lucentis, has been granted marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 17 January 2023
Biosimilars
Shares of India’s largest biotech firm Biocon slumped 2.4% to record a new 52-week low, after its subsidiary Biocon Biologics informed that the US Food and Drugs Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for its Insulin-R product. 13 January 2023
Biosimilars
California, USA-based Coherus BioSciences’ shares closed up almost 10% at $9.85 yesterday, when it announced the execution of a binding term sheet with Germany’s Klinge Biopharma for the exclusive US commercialization rights to FYB203, a biosimilar candidate to Eylea (aflibercept). 11 January 2023
Biosimilars
Icelandic firm Alvotech and the US subsidiary of Israel’s Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Johnson & Johnson’s Stelara (ustekinumab). 6 January 2023
Biosimilars
South Korea’s Samsung Bioepis says that Health Canada has approved its Hadlima (also known as SB5) - a citrate-free, high concentration (40mg/0.4 ML) formulation of biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 3 January 2023
Biosimilars
South Korea’s Celltrion Healthcare has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for its lead product candidate, CT-P13 SC (also known as Remsima), which is the subcutaneous formulation of infliximab, to the US Food and Drug Administration (FDA). 28 December 2022
Biosimilars
The European Commission has published a study examining the public procurement practices and their impact on medicines supply and availability. The study confirms that awarding multiple winners and using additional criteria other than price (most economically advantageous tender – MEAT criteria) would be more sustainable procurement. 22 December 2022
Biosimilars
Canada’s largest public drug plan has announced a transition to cost-saving biosimilar medicines. 21 December 2022
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