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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Biosimilar medicines deliver access for patients suffering from serious and debilitating conditions such as cancer, auto immune diseases, and diabetes. 13 December 2022
The US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) submitted by biotech major Biogen for BIIB800, a biosimilar candidate referencing Roche’s Actemra, an anti-interleukin-6 receptor monoclonal antibody. 12 December 2022
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news
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.