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Commission (FTC) said yesterday that it has submitted a comment supporting the Food and Drug Administration’s (FDA) draft guidance regarding interchangeable biosimilar drugs. 23 August 2024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
The Generic Medicines Industry Association (GMiA) has signed a strategic agreement with the Australian government to support the ongoing supply of affordable generic and biosimilar medicines in Australia and deliver a five year period of certainty for the industry that provides them. 27 May 2015
The Finnish Medicines Agency, Fimea, has presented its position towards interchangeability of biosimilars licensed in the European Union. The position is a recommendation to the local health care system. 26 May 2015
Korean biopharma company Celltrion Healthcare has presented data on the clinical experience of patients using its biosimilar infliximab, showing its treatment is comparable to the reference product in terms of safety and efficacy. 19 May 2015
Biopharma companies Epirus and mAbxience have entered into a development and future distribution deal for Epirus’ lead program, BOW015 (infliximab) for Latin American markets. 14 May 2015
The USA’s Generic Pharmaceutical Association (GPhA) and its Biosimilars Council applaud the enactment of legislation in five states to allow automatic substitution for Food and Drug Administration approved interchangeable biologic product, or biosimilars. 14 May 2015
India’s Biocon, Asia’s premier biotechnology company, says that it has made clinical progress in its partnered programs with US generics major Mylan. 11 May 2015
The US Court of Appeals for the Federal Circuit issued an injunction this week blocking Swiss pharma major Novartis’ US generics subsidiary Sandoz Inc from selling a biosimilar version of Amgen’s drug Neupogen (filgrastim) 7 May 2015
In Italy, potential savings for patients from the use of generic medicines is 1.4 billion euros ($1.59 billion) per year, according to a new report. 7 May 2015
The European Generic and Biosimilar medicines Association (EGA) organized a roundtable on ‘Universal Access to Health, a year after the European Union elections’ today in Brussels together with the European Patients Forum, International Association of Mutual Benefit Societies and Doctors of the World. 5 May 2015
The Australian Generic Medicines Industry Association (GMiA) says it welcomes the decision of the Pharmaceutical Benefits Advisory Committee (PBAC) to consider “a” flagging of biosimilars, and to list biosimilar insulin (Basaglar) on the Pharmaceutical Benefits Scheme (PBS). 1 May 2015
US drug companies Coherus BioSciences and Baxter International have amended certain financial terms of their 2013 collaboration agreement regarding the development and commercialization of CHS-0214, an etanercept biosimilar product candidate. 15 April 2015
Injectables specialist and global biosimilars leader Hospira said that it is essential that biosimilar drugs are given the same non-proprietary names as original biologics to ensure patient access and lower costs. 13 April 2015
January 7, 2015 witnessed the dawning of the era of biosimilars in the United States, writes Cecil Nick, Vice President - Technical, PAREXEL International. 10 April 2015
The Canadian Generic Pharmaceutical Association (CGPA) has established a new CGPA Biosimilars board and has elected Michel Robidoux, president and general manager of Sandoz Canada, as its inaugural chairman. 8 April 2015
The Netherlands’ Medicines Evaluation Board (MEB) has updated its position about biosimilar medicinal products, saying that biosimilars have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality, safety and efficacy are concerned. 7 April 2015
The US Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with the biosimilars deal between US biotech firm Pfenex and Hospira. 23 March 2015
Speaking at the first Biological Medicines Forum organized by the Associations last week, the president of trade group Farmaindustria, Antoni Esteve, defended the principle of non-interchangeability of biological and biosimilar medicines. “Only an individualized deliberation might advise to change a treatment which is already working well for a given patient,” he said. 21 March 2015
The US district court has rejected Amgen’s request for a preliminary injunction to block Sandoz’s Neupogen (fligrastim) biosimilar Zarxio (fligrastim-sndz). 20 March 2015
The Australian Generic Medicines Industry Association (GMiA) has today launched the GMiA Guide to Biosimilars during a Parliamentary Friends of Medicine event at Parliament House. 17 March 2015
South Korea-based Samsung Bioepis, a joint venture between Samsung and US biotech firm Biogen Idec, says it has submitted Marketing Authorization Application for SB2, its biosimilar candidate Remicade (infliximab), market in Europe by Johnson & Johnson, to the European Medicines Agency. 13 March 2015
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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.