3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
The Biosimilars Council, alongside the Association for Accessible Medicines (AAM), released its 2024 US Generic & Biosimilar Medicines Savings Report. 6 September 2024
Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024
Biocon Biologics has signed a settlement and license agreement with Johnson & Johnson that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab), in Europe, the UK, Canada, and Japan. 3 September 2024
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Celltrion’s US subsidiary has signed an agreement with pharmacy benefit managers (PBMs) Cigna Healthcare, and Express Scripts that will help expand patient access to Zymfentra (infliximab-dyyb). 29 August 2024
Drug development consultancy Certara has published a report on the Inflation Reduction Act’s (IRA) impact on oncology biosimilar uptake. 29 August 2024
South Korea’s Celltrion yesterday announced the European Commission (EC) approval for the use of SteQeyma (CT-P43), an ustekinumab biosimilar referencing Stelara, for the treatment of multiple chronic inflammatory diseases. 27 August 2024
The USA’s Federal Trade Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024
The US subsidiary of South Korea’s Celltrion announced its US Food and Drug Administration (FDA)-approved biosimilar adalimumab-aaty has been added to the Costco member prescription program. 14 August 2024
The US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2mg vial kit and pre-filled syringe for intravitreal injection, developed by Swiss biosimilars company Sandoz. 12 August 2024
The Biosimilars Council—part of the USA’s Association for Accessible Medicine (AAM) representing companies developing off-patent medicines—has provided an update on its activities on the regulatory, legislative and educational fronts. 5 August 2024
Chinese biotech Bio-Thera Solutions (SHSE: 688177) has picked up European Medicines Agency approval for BAT1706, a biosimilar referencing Avastin (bevacizumab). 1 August 2024
The US Food and Drug Administration (FDA) has issued a Federal Register notice, “Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments.” 25 July 2024
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. 23 July 2024
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). 22 July 2024
The US trade association representing pharmacy benefit managers has said that new bipartisan legislation will bring generic drugs to market sooner. 22 June 2016
Groups representing Europe’s pharma, biotech and generics companies have welcomed the European Commission’s staging of a workshop on the uptake of biosimilars. 20 June 2016
Sandoz, the generics and biosimilars division of Swiss pharma giant Novartis, plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020, aiming at broadening access to these treatments for more patients. 20 June 2016
Access to affordable biosimilars is around the corner in India, with the government looking to release guidelines after nearly two years of consultations with the pharma industry and the Central Drugs Standard Control Organization (CDSCO), reports The Pharma Letter’s India correspondent. 20 June 2016
Medicines for Europe, the trade group representing the continent’s generics and biosimilars industry, has said it will work with health ministers to ensure swift implementation of calls for greater pharma competition which were made in the council of the European Union this week. 17 June 2016
India’s Zydus Cadila and Turkish healthcare company Eczacıbaşı İlaç Pazarlama have signed a strategic collaboration agreement to market biotech products in the Turkish market. 15 June 2016
Leading Russian biotech firm Biocad has filed a petition to the New York Federal Court against Swiss pharma giant Roche, accusing the company of setting monopoly-low prices for its products in Russia, with the aim of ruining business of local competitors, reports The Pharma Letter’s local correspondent. 14 June 2016
Japanese companies Mitsubishi Gas Chemical and Nippon Kayaku have newly established a joint venture company for production of monoclonal antibody pharmaceuticals (MAbs) including biosimilars. 10 June 2016
South Korean drug developer Samsung Bioepis has announced new data on three of the candidates in its promising biosimilar pipeline at the Annual European Congress on Rheumatology (EULAR 2016). 9 June 2016
Antibody-positive patients who are being treated with the rheumatoid arthritis treatment Remicade (infliximab) should not be switched to a biosimilar version. 9 June 2016
Alvotech, an independent sister company of privately-held US generics firm Alvogen, has announced the opening of a new state-of-the-art facility, dedicated to the development and manufacturing of biosimilar monoclonal antibodies (MAbs). 9 June 2016
The European Commission has granted marketing authorization in the European Union for Flixabi, an infliximab biosimilar referencing Remicade, Johnson & Johnson and Merck & Co's Remicade (infliximab). 31 May 2016
Adoption of the European Parliament’s report on the Single Market Strategy in Plenary has been applauded by Medicines for Europe, which represents generic and biosimilar medicines producers in Europe. 26 May 2016
Vifor Pharma has further expanded its erythropoiesis stimulating agent (ESA) portfolio with the licensing of commercialization rights in the US dialysis market to Pfizer's Retacrit, a proposed biosimilar epoetin, in the field of nephrology. 24 May 2016
Sandoz, Swiss pharma giant Novartis' generics and biosimilars business, says that the European Medicines Agency has accepted its Marketing Authorization Application for a biosimilar to Roche's blockbuster drug MabThera (rituximab). 24 May 2016
South Korea-based Samsung Bioepis revealed today that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab). 24 May 2016
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Company Spotlight
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.