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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
Sanofi said today that it filed a patent infringement suit against US peer Merck & Co on September 16, 2016 in the USA District Court for the District of Delaware. In its suit Sanofi alleges infringement of 10 patents relating to its blockbuster diabetes treatment Lantus (insulin glargine). 19 September 2016
Biosimilar medicines provide a tremendous opportunity for governments throughout Europe to increase patient access to treatment with modern biologic therapies while at the same time supporting the sustainability of healthcare budgets. 19 September 2016
Commenting on the release last week of the Biosimilar User Fee Act (II) performance goals letter, trade group Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive Stephen Ubl welcomed the move, saying: "The Biosimilar User Fee Act (BsUFA) is critical to supporting the US Food and Drug Administration (FDA) in its core mission of protecting public health.” 19 September 2016
Samsung Bioepis says that its Brenzys – also known as SB4, a biosimilar to Enbrel (etanercept), has received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. 13 September 2016
Janet Woodcock, director of the US Food and Drug Administration Center for Drug Evaluation and Research (CDER) delivered a keynote address at Leading on Biosimilars: The 2016 GPhA Biosimilars Council Conference. 12 September 2016
Announcing an “unprecedented” positive court decision in its patent Infringement litigation against Amgen concerning its Grastofil (filgrastim) – a biosimilar of Amgen’s Neupogen - and Lapelga (pegfilgrastim) – Amgen’s Neulasta - products, Apobiologix also indicates that the company has filed a Petition for Certiorari with the US Supreme Court. 10 September 2016
In our quarterly special report, Dr Michelle Maxwell examines the fast-moving world of biosimilars and explores the opportunities opening up for biosimilar developers as patent exclusivity expires on numerous biologic medicines over the next ten years. 8 September 2016
Flixabi, a biosimilar version of US health care giant Johnson & Johnson’s inflammatory diseases drug Remicade (infliximab), has been launched in the UK. 8 September 2016
In our weekly expert view piece, Stacie Ropka, an IP attorney, and William Rose, an associate, from Axinn Veltrop & Harkrider, examine the biosimilar approval process in the EU compared to the US. 6 September 2016
Sandoz has received US Food and Drug Administration approval for Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). 31 August 2016
Netherlands-based generics major Mylan and Indian drugmaker Biocon have had their regulatory submission for a trastuzumab biosimilar accepted by the European Medicines Agency (EMA). 25 August 2016
Australia’s Pharmaceutical Benefits Scheme Committee has recommended the listing of Brenzys as a biosimilar of originator brand etanercept (Enbrel) on a cost minimization basis with Enbrel for all adult indications – rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and chronic plaque psoriasis. 19 August 2016
Johnson & Johnson has confirmed a negative US court ruling relating to a biosimilar version of its blockbuster rheumatoid arthritis drug Remicade (infliximab). 18 August 2016
The European Medicines Agency has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), titled “Product- or population-specific considerations II: Biological medicinal products.” 15 August 2016
US drugmaker AbbVie has launched legal proceedings to prevent rival company Amgen from marketing a biosimilar version of its blockbuster arthritis drug Humira (adalimumab). 8 August 2016
The companies aiming to take advantage of patent expiries of some of the world’s best-selling biologics – be they the Sandoz unit of Swiss pharma giant Novartis, US biotech majors Amgen and Biogen or others of similar ilk – are some of the industry’s big players. 5 August 2016
Biocon says that, close on the heels of receiving approval for its insulin glargine from the Japanese regulator last quarter, its partner Fujifilm Pharma (FFP) has now launched the product in Japan. 20 July 2016
The race to come up with a biosimilar version of the rheumatoid arthritis treatment Humira (adalimumab) – the world’s top-selling drug – is well and truly on. 18 July 2016
South Korean drug developer Samsung Bioepis has had its marketing authorization application (MAA) for a biosimilar candidate referencing big-selling arthritis drug Humira (adalimumab) accepted for review by the European Medicines Agency. 18 July 2016
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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.