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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
German drugmaker STADA Arzneimittel will from June add to its team by welcoming Dr Christine Berndt as head of global development Specialties/Biosimilars. 22 April 2022
Iceland-based Alvotech Holdings today announced the resolution of all intellectual property disputes with AbbVie in Europe and selected markets outside of Europe, related to its AVT02 biosimilar candidate. 6 April 2022
According to a report from the US Department of Health and Human Service (HHS) Office of Inspector General (OIG), Biologics - usually large, complex molecules produced in a living system - are some of the most expensive drugs available, and spending for biologics is growing in Medicare Part D because they treat diseases common among Medicare beneficiaries. 4 April 2022
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorization for Inpremzia, a biosimilar version of Actrapid (human insulin). 1 April 2022
Munich, Germany-based Formycon shares rose almost 12% to 62.40 euros yesterday, after it revealed that it has agreed to merge its development activities in the area of biosimilars through a long term strategic partnership with ATHOS AG. 30 March 2022
China’s Fosun Pharma’s biotech arm Henlius is preparing to get its PD1 antibody serplulimab into hospitals nationwide once it is approved in China, and supply its four approved biosimilars with enhanced manufacturing capacity, said Henlius chief executive Zhang Wenjie at a press meeting held in Shanghai on March 17. 22 March 2022
As the World Health Organization (WHO) considers amending guidelines for evaluating biosimilars so that Phase III clinical trials can be waived for biosimilar products, India may take a greater interest in developing biosimilars. 14 March 2022
Samsung Bioepis and the Canadian subsidiary of US biotech major Biogen today announced that Health Canada has approved Byooviz – a biosimilar referencing Lucentis (ranibizumab). 10 March 2022
Privately-held Icelandic biosimilars developer Alvotech Holdings says it has executed a US settlement agreement with AbbVie that grants Alvotech non-exclusive rights to market AVT02 (100mg/mL), its high-concentration, citrate-free biosimilar candidate for Humira (adalimumab) in the USA 9 March 2022
The US Food and Drug Administration yesterday published a funding opportunity announcement (FOA) to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science. 8 March 2022
The US Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) submitted by pharma giant Pfizer for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). 26 February 2022
South Korea’s Celltrion Healthcare announced new data sets on the SC formulation of infliximab, Remsima (CT-P13) in IBD, at the European Crohn’s and Colitis Organization (ECCO) virtual congress 2022. 21 February 2022
Even as US President Joe Biden called for the US Senate to approve his Build Back Better legislation to reduce the costs of prescription drugs provided through Medicare and cap out-of-pocket drug costs for seniors, including insulin at $35 per month, Indian drug manufacturers are expecting an even stronger focus on generics and biosimilars, reports The Pharma Letter’s India correspondent. 17 February 2022
US biotech major Biogen and Swedish firm Xbrane Biopharma have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane, a pre-clinical monoclonal antibody that is a proposed biosimilar referencing Cimzia (certolizumab pegol). 10 February 2022
Indian drugmaker Lupin Limited today revealed it has entered into a license, supply and technology sharing agreement with Axantia Holding for the distribution of its Pegfilgrastim, a biosimilar of Amgen’s Neulasta (pegfilgrastim). 1 February 2022
South Korea-based Samsung BioLogics has reached an agreement for the buyout of Biogen's (Nasdaq: BIIB) stake in their biosimilars joint venture, Samsung Bioepis, for $2.3 billion. 28 January 2022
Hailing the benefits of 15 years of biosimilar prescribing in Europe, The Biosimilar Medicines Group has called on the European Medicines Agency to take stronger action to widen access to this type of medicine. 25 January 2022
The ongoing review of the European pharmaceutical legislation framework is a major opportunity to update the regulatory system in the European Union, says Medicines for Europe, which represents the generics and biosimilars drugmakers. 24 January 2022
Biosimilars focussed Icelandic company Alvotech Holdings and Oaktree Acquisition Corp. II (Oaktree II), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, today announced $21 million in additional commitments for a private placement (PIPE) of Oaktree II common stock in connection with their proposed business combination. 19 January 2022
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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.