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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
With the high cost associated with branded biologics, the healthcare industry has seen a growing interest in biosimilars. However, significant barriers to accessing alternatives to biologics still exist, writes Dr Nicola Davies in her monthly FDA blog for The Pharma Letter. 4 June 2018
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including two orphan medicines, at its May 28-31, 2018 meeting. 2 June 2018
As the American Society for Clinical Oncology (ASCO) conference got underway on Friday, Samsung Bioepis revealed the results of a one-year follow-up study on SB3, its biosimilar alternative to Roche's blockbuster breast and stomach cancer treatment Herceptin (trastuzumab). 1 June 2018
Following the receipt of two Complete Response Letters from the US Food and Drug Administration related to manufacturing issues, US pharma giant Pfizer's Retacrit was finally cleared for marketing. 1 June 2018
At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, USA, South Korean biosimilars maker Celltrion Healthcare advocated for healthcare systems to introduce biologics earlier in a patient’s treatment regimen in order to improve clinical outcomes. 22 May 2018
Russian biosimilar manufacturer Biocad has had its rituximab equivalent approved by the Cuban Ministry of Health, and will begin issuing the drug to patients by the end of 2018. 17 May 2018
As a result of biosimilars slow entry into the US market, the Food and Drug Administration is taking proactive measures to ensure the continued growth of the biosimilars market by educating patients and physicians through online resources and information campaigns to encourage more competition and lowered prices of biologics. 14 May 2018
A new report from industry analyst Kalorama Information estimates that the global market for biosimilars will be worth almost $6.2 billion by the end of the year. 9 May 2018
A new name is now listed among the member companies of the official trade association for the European generic, biosimilar and value-added pharmaceutical industries. 8 May 2018
Although US drugmaker AbbVie has done a sterling job in fending off competition to its Humira (adalimumab), the world’s biggest selling medicine and still growing, at least in Europe, that is all likely to come to an end later this year. 4 May 2018
The Mundipharma global network of independent associated companies today announced that Herzuma, biosimilar trastuzumab, is now available in Europe, with the product now launched in both the UK and Germany and further launches across European countries anticipated in the coming months. 3 May 2018
The US Food and Drug Administration has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for Sandoz’ proposed biosimilar rituximab. 3 May 2018
Since October of 2017, US drugmaker AbbVie has reached two settlements with biosimilar manufacturers over the entry date of their biosimilar versions of Humira (adalimumab) into the US market. 24 April 2018
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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.