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.
The opportunities created, and necessary standards needed, by biosimilar drugs in order to deliver sustainable cancer care are outlined in a position paper from the European Society for Medical Oncology (ESMO). 18 January 2017
Boehringer Ingelheim is the latest to announce that its biosimilar to AbbVie’s (NYSE: ABBV) blockbuster drug Humira (adalimumab), BI 695501, has been accepted for regulatory review by the European Medicines Agency and the US Food and Drug Administration. 18 January 2017
The United States Supreme Court has agreed to hear a case that will determine whether companies that develop biosimilar versions of biologics must wait six months before launching them in the USA. 16 January 2017
No company makes more money from a drug than US pharma major AbbVie does from its arthritis treatment Humira (adalimumab), but how long that will go on for could be determined by a UK court case starting on Monday. 14 January 2017
Netherlands-incorporated generics major Mylan and Indian biotech Biocon are a step closer to gaining approval for a biosimilar version of Herceptin (trastuzumab) in the USA. 11 January 2017
Pfizer says its comparative, confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12. 6 January 2017
UK-based Mundipharma has made steps towards its goals of becoming a leader in the biosimilars field and in growing its respiratory pipeline, it has announced this week. 23 December 2016
A year after its approval by the US Food and Drug Administration, a follow-on version of Sanofi’s blockbuster long acting insulin product Lantus (insulin glargine) has hit the market. 16 December 2016
The 2017 Finance Bill, recently approved by the Republic of Italy's Senate, includes important provisions favoring biosimilar medicines, a significant landmark that will increase competition among biotech drug companies. 14 December 2016
South Korea’s Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organization (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD). 12 December 2016
Biopharma company JHL Biotech, which has development and manufacturing facilities in Wuhan and Taiwan, has entered into a strategic alliance to collaborate on the development and commercialization of biological therapeutics in China and with potential international expansion. 5 December 2016
A Marketing Authorization Application (MAA) to the European Medicines Agency for ABP 215, a biosimilar candidate to Swiss pharma major Roche’s blockbuster cancer drug Avastin (bevacizumab). 3 December 2016
US pharma giant Pfizer has released top-line results from the REFLECTIONS B3271002 study of its potential trastuzumab biosimilar, PF-05280014, showing it met its primary endpoint. 1 December 2016
The line-up of near-term biosimilar competitors to AbbVie’s blockbuster Humira (adalimumab) – which generates annual sales of some $15 billion - is getting ever longer, even as the originator is still expressing confidence on its intellectual property protecting its market exclusivity. 29 November 2016
Roman Ivanov, vice president of research and development (R&D) at Biocad, describes his company’s current transition as going from being a local biosimilar player in its native Russia, to a global mid-sized biopharmaceutical player, in an intreview with The Pharma Letter's Guy Martin. 29 November 2016
Trade group Medicines for Europe, which represents the generics and biosimilars sector, has taken issue with the report ‘Health at a Glance 2016’ launched yesterday prepared by the Organization for Economic Co-operation and Development (OECD) for the European Commission. 28 November 2016
Sandoz, the biosimilars division of Swiss pharma giant Novartis, has announced new results from the EGALITY trial, a confirmatory clinical safety and efficacy study comparing its biosimilar version of etanercept to the originator product, Enbrel. 25 November 2016
In-depth research from over 400 Indian pharma companies, which forecasts rapid growth for the Indian pharma economy in 2017, was presented at CPhI and P-MEC India, part of India Pharma Week which closed yesterday. 24 November 2016
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
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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.