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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
All news
Biosimilars
The US Food and Drug Administration approved the first interchangeable biosimilar insulin product, Semglee (insulin glargine-yfgn). 29 July 2021
Biosimilars
Indian drugmaker Intas Pharmaceuticals has been granted rights to commercialize DMB-3115, a proposed biosimilar to Janssen’s Stelara (ustekinumab), in all global markets excluding Japan, South Korea and certain other Asian countries. 26 July 2021
Biosimilars
The Food and Drug Administration (FDA) has issued an untitled letter to US biotech giant Amgen for the misbranding of its biological product, Neulasta (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication. 15 July 2021
Biosimilars
The International Generic and Biosimilar Medicines Association (IGBA) has launched a whitepaper: A Vision for the Global Generic and Biosimilar Medicines Industry, which covers the strong contribution of this pharmaceutical sector to global health outcomes and economies, the opportunities, challenges and disruptions for the industry, its 2030 vision as well as actions needed to achieve this vision. 8 July 2021
Biosimilars
Biosimilar competition has the potential to provide greater access to important treatments for America’s patients and cost savings for the nation’s health care system of as much as $130 billion by 2025, notes the Biosimilars Council, a division of the USA’s Association for Accessible Medicines (AAM). 7 July 2021
Biosimilars
Indian pharmaceutical companies focusing on US generics are building specialty generics pipelines. Price erosion due to increased competition in the USA has hastened Indian drug firms' push towards specialty medicines. The complexity being tapped is the active pharmaceutical ingredient (API) or formulation routes of delivery, a complex dosage form, or where the approval pathway has changed, reports The Pharma Letter’s India correspondent. 30 June 2021
Biosimilars
German drugmaker STADA Arzneimittel and its biosimilar development partner Swedish firm Xbrane Biopharma have announced that their ranibizumab biosimilar candidate met its primary endpoint in a pivotal comparability trial involving 583 patients. 30 June 2021
Biosimilars
Israeli generics giant Teva Pharmaceutical Industries and Swiss firm Bioeq today announced a strategic partnership for the exclusive commercialization of Bioeq's FYB201, a biosimilar candidate to the ophthalmic drug Lucentis (ranibizumab) in Europe, Canada, Israel and New Zealand. 28 June 2021
Biosimilars
China’s Bio-Thera Solutions has recently initiated a Phase III trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe. Against this backdrop, BAT2506 is the first subcutaneous golimumab biosimilar. 23 June 2021
Biosimilars
Shares of pharmaceutical companies continued their upward journey at the bourses in India, with the pharma index hitting a new high. Pharma stocks are in focus amid the ongoing COVID-19 pandemic, helping register a strong gain for companies like Aurobindo Pharma, Dr Reddy’s Laboratories and Cadila Healthcare, reports The Pharma Letter’s India correspondent. 15 June 2021
Biosimilars
South Korean biosimilars specialist Celltrion Healthcare has presented new Phase IV data for Truxima (rituximab-abbs) at the annual meeting of the European Hematology Association (EHA). 14 June 2021
Biosimilars
Women’s health company Theramex has entered into an agreement to register and commercialize a biosimilar version of Prolia (denosumab) from Enzene Biosciences for use in Europe, the UK, Switzerland, and Australia. 10 June 2021
Biosimilars
Cadila Healthcare is among the leading players in India which focuses on bringing in-house developed innovative therapies for patients. Cadila Healthcare has developed a diversified COVID-19 portfolio among the Indian players through in-house development and licensing opportunities. 2 June 2021
Biosimilars
ProBioGen and Egyptian firm Minapharm Pharmaceuticals, which owns 96.79% of Germany-based ProBioGen, have announced the incorporation of ProBioGen's subsidiary MiGenTra GmbH with headquarters in Berlin and access to a site in Cairo, which will house its principal manufacturing plant. 27 May 2021
Biosimilars
Medicines for Europe, the trade group representing the generics and biosimilars industry in Europe, has welcomed an update to the 2020 industrial strategy published by the European Commission (EC). 18 May 2021
Biosimilars
The US Supreme Court has denied the petition to review the Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept), sold by US biotech major Amgen. 18 May 2021
Biosimilars
Recently-formed Viatris, the combination of Mylan with Pfizer’s Upjohn business, has reported results for the first quarter of 2021, which demonstrate the strength of its differentiated operating platform and commercial capabilities, its broad and diverse product portfolio and its strong R&D platform, the company said. 15 May 2021
Biosimilars
US pharma major AbbVie has answered back in its latest row over Humira (adalimumab), the inflammatory diseases drug that it continues to sell without competition in the USA. 14 May 2021
Biosimilars
The US Food and Drug Administration has published the guidance for industry entitled “M9 Biopharmaceutics Classification System-Based Biowaivers,” a draft of which was issued in October 2018. The guidance provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of the in vivo bioequivalence study requirement for drug products. 14 May 2021
Biosimilars
Privately-held Icelandic biopharmaceutical company Alvotech, which is seeking to become one of the leaders in the biosimilar monoclonal antibody market, has made a statement this week by filing a lawsuit against AbbVie. 12 May 2021
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