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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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 Food and Drug Administration (FDA) yesterday announced it has approved US biotech major Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. 1 November 2023
Indian pharmaceutical companies are demonstrating a growing commitment to advancing cancer treatment through substantial investments in biologics. 31 October 2023
Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis that was fully spun out on October 4, announced the issuance of two highly successful inaugural CHF bonds with gross proceeds of 750 million francs ($843 million). 27 October 2023
The European Union is currently reviewing its pharmaceutical legislation, and the latest IQVIA white paper “Assessing the biosimilar void” sheds light on the growing biological medicines market and the opportunity to improve equitable access with biosimilar medicines competition. 26 October 2023
The US business of South Korea's Celltrion Healthcare has secured approval for Zymfentra (infliximab-dyyb), a subcutaneous reformulation of infliximab. 24 October 2023
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Icelandic firm Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Johnson & Johnson Stelara (ustekinumab). 12 October 2023
Samsung Bioepis, a business of South Korea-based Samsung BioLogics has outlined data it is presenting at the ongoing congress of the European Academy of Dermatology and Venereology (EADV). 11 October 2023
The US subsidiary of South Korea's Celltrion Healthcare has announced the signing of an important contract with Ventegra, a US medical benefits manager (MBM). 6 October 2023
The market for biosimilar versions of AbbVie’s mega-blockbuster TNF blocker Humira (adalimumab) is hotting up, with a major price reduction from Boehringer Ingelheim. 4 October 2023
Medicines for Europe, the trade organization representing generics and biosimilars drugmakers, today highlighted the need for a security act for the European Union to provide health security. 2 October 2023
As Indian pharma majors take giant strides in biosimilars development, Indian policymakers are under pressure to contemplate a set of regulatory changes aimed at promoting their development. 2 October 2023
The US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra. 30 September 2023
A Chinese contract development and manufacturing organization (CDMO), Chime Biologics, has announced a strategic cooperation with South Korea’s Kings Pharm. 29 September 2023
The European Commission (EC) granted marketing authorization for Tyruko (natalizumab), the first and only biosimilar multiple sclerosis drug, developed by Dutch company Polpharma Biologics. 26 September 2023
Chicago, USA-based Meitheal Pharmaceuticals has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical to commercialize three insulin biosimilars in the USA. 22 September 2023
Following a favorable recommendation form the European Medicines Agency’s advisory committee on July, the European Commission (EC) has now granted marketing authorization in the European Union (EU) for Indian drugmaker Biocon’s Yesafili, a biosimilar of Eylea (aflibercept). 21 September 2023
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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.