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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
A new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) found that Canadian physicians overwhelmingly support distinguishable names for all biologics, including biosimilars. 23 November 2017
The 1st Value Added Medicines conference organized by the Value Added Medicines Group, a sector group of the generics and biosimilars trade group Medicines for Europe, which took place today, November 22, gathered a wide range of experts in the healthcare community to raise awareness and foster debate on a common approach to present solutions for patient-centric innovation and better patient access to these medicines. 22 November 2017
Samsung Bioepis has had its marketing authorization of Ontruzant, a biosimilar referencing Herceptin (trastuzumab), approved by the European Commission (EC). 20 November 2017
US healthcare giant Johnson & Johnson has dropped its lawsuit against Samsung Bioepis relating to the latter’s biosimilar of the blockbuster rheumatoid arthritis treatment Remicade (infliximab). 14 November 2017
A few companies have taken big strides in moving their biosimilar portfolios forward in Europe and the USA this year – with Samsung Bioepis, Boehringer Ingelheim and Amgen among the undisputed frontrunners in this burgeoning field. 14 November 2017
The European Commission followed in the footsteps of the US Food and Drug Administration (FDA) by approving the Humira (adalimumab) biosimilar being developed by privately-owned drugmaker Boehringer Ingelheim. 13 November 2017
A panel of analysts and investors have told a conference that the threat of biosimilars to the reference drug manufacturers should not be underestimated. 10 November 2017
FDA Commissioner Scott Gottlieb has announced new draft guidance for the pharmaceutical industry affecting Risk Evaluation and Mitigation Strategies (REMS) submissions. 9 November 2017
Korean drugmaker Celltrion Healthcare has presented data supporting switching to its biosimilar version of a big-selling biologic from the Swiss pharma giant Roche. 6 November 2017
Following in the footsteps of US drug giant Pfizer, a New York grocery union benefits fund has sued Johnson & Johnson for allegedly abusing its monopoly power to exclude competition and raise prices for Remicade (infliximab). 1 November 2017
US drug giant Pfizer and its South Korean partner Celltrion have armed themselves with more evidence to aid their efforts to replace Remicade’s (infliximab) share of the Crohn’s Disease (CD) market. 31 October 2017
In the week that it announced its latest plans to enter European markets, Russia’s largest biotech company, BIOCAD, has come out on top in a patent dispute in its native country involving rituximab. 25 October 2017
Biosimilars could cut healthcare spending in the USA by $54 billion over the next decade, says a study from the RAND Corporation, a nonprofit institution that helps improve policy and decision-making through research and analysis. 20 October 2017
Generic drugmakers and research-based pharma companies are used to facing each other in patent rows that can bring lost or gained earnings totaling many millions of dollars, but billions are riding on a European Union (EU) review of laws affecting exclusivity periods for the industry as a whole. 18 October 2017
The overall industry pipeline for monoclonal antibodies (MAbs) has reached an unprecedented scale, now accounting for almost 3,000 distinct pipeline programs across a range of therapy areas. 17 October 2017
Ukrainian trade group The Association of Pharmaceutical Research and Development (APRaD) has called for changes to be made to the regulation and implementation of biosimilars in the region. 16 October 2017
A group representing the industry that supplies more than 60% of Europe’s medicines has hit out at the low prices being paid for these drugs. 29 September 2017
AbbVie today announced a global resolution of all intellectual property-related litigation with biotech major Amgen over the latter’s proposed biosimilar to AbbVie's mega-blockbuster rheumatoid arthritis and inflammatory diseases drug Humira (adalimumab). 28 September 2017
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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.