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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
Indian drugmaker Biocon says that its subsidiary Biocon Biologics has completed the integration of the acquired biosimilars business in over 70 countries in emerging markets effective July 1, 2023, ahead of schedule, increasing the scale and scope of its business. 7 July 2023
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics today provided an update on the deal it announced last month with US pharma major Pfizer. 4 July 2023
Pharmsynthez, one of Russia's leading drugmakers, is accelerating its expansion in the domestic market by investing more than 20 billion roubles ($223 million) in the building of one of Russia’s largest complexes for the production of active ingredients and finished dosage forms within the territory of the Vorotynsk Industrial Park in the Kaluga region. 4 July 2023
A life-changing treatment to prevent blindness in premature babies is to be routinely available on England’s National Health Service (NHS), it was revealed today. 4 July 2023
The general assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has adopted a new topic focused on the harmonization of bioequivalence for modified-release products. 3 July 2023
With the block on biosimilar versions of AbbVie’s (NYSE: ABBV) mega blockbuster Humira (adalimumab) now removed in the USA, the weekend witnessed the launch of three copycat products in the American market. 3 July 2023
Medicines for Europe, the trade body for generics and biosimilars companies in the region, has called for “a fair, cost-based approach” to regulatory fees. 30 June 2023
Deficiencies identified by the US Food and Drug Administration (FDA) at Icelandic biosimilar firm Alvotech’s Reykjavik facility have resulted in a second complete response letter (CRL) for AVT02, its copy of Humira (adalimumab). 30 June 2023
German family-owned pharma major Boehringer Ingelheim has revealed that Optum Rx, a leading pharmacy benefit manager and subsidiary of UnitedHealth Group, will place Cyltezo (adalimumab-adbm) on its commercial formulary as a preferred brand, which covers more than 66 million members. 24 June 2023
Indian drugmakers Alkem Laboratories and Lupin Limited have recently launched the world’s first cetuximab biosimilar in India for the treatment of head and neck cancer (HNC). 16 June 2023
Medicines for Europe has said that it sees the revision of European Union (EU) pharmaceutical legislation as an opportunity to accelerate patient access to safe, effective, and affordable medicines and to improve security of supply. 15 June 2023
Generics and biosimilar medicines company Sandoz has trumpeted the launch of what it calls a ‘global roadmap to increase patient access to biologic medicines’. 15 June 2023
Generic and biosimilar medicines significantly lower healthcare treatment costs and are essential for enabling competition and vastly improved access to medicines, says a leading European trade group. 13 June 2023
Icelandic firm Alvotech and the US unit of Israel’s Teva Pharmaceutical Industries today revealed they have reached a settlement and license agreement with Johnson & Johnson concerning AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab) in the USA. 12 June 2023
Sandoz, the generics and biosimilars unit of Novartis, has outlined an ambitious plan for its newly-independent future once the spin-out from its parent is complete. 9 June 2023
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics today revealed it has entered another strategic partnership with US pharma giant Pfizer (NYSE: PFE). 8 June 2023
The US biosimilar drug market emerged in 2015 to provide safe, effective, and more affordable alternatives to existing biologic drugs, but it has been slow to develop compared with Europe. 7 June 2023
US biosimilars developer Coherus BioSciences saw its share rise 5% to $4.05 pre-market, after it announced it will launch Yusimry (adalimumab-aqvh) next month. 2 June 2023
South Korean drugmaker Samsung Bioepis today announced that the European Commission (EC) has granted marketing authorization for Epysqli, a biosimilar to medicine to AstraZeneca’s Soliris (eculizumab), for the treatment of adult and child patients with paroxysmal nocturnal hemoglobinuria (PNH). 30 May 2023
The US Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) biosimilar, the US subsidiary of South Korean biosimilars developer Celltrion Healthcare. 26 May 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.